azur cx 35 peripheral coil system (detachable ... · - 1 - azur cx 35 peripheral coil system...

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Azur CX 35 Peripheral Coil System (Detachable)

Instructions for Use

DEVICE DESCRIPTION

The Detachable Azur CX 35 Peripheral Coil System (Azur system) consists of a coil implant attached to a delivery system. The coils are platinum-based coils with an inner layer of hydrophilic polymer. The delivery pusher is powered by an Azur Detachment Controller to selectively detach the coils. The Azur Detachment Controller is provided separately.

The Azur system is available in a broad range of coil diameters and lengths. The AZUR Detachable 35 coil must be delivered through a double-braid reinforced catheter with the inner diameter specified.

Table 1

INDICATIONS FOR USE

The Azur system is intended to reduce or block the rate of blood flow in vessels of the peripheral vasculature. It is intended for use in the interventional radiologic management of arteriovenous malformations, arteriovenous fistulae, aneurysms, and other lesions of the peripheral vasculature.

This device should only be used by physicians who have undergone training in the use of the Azur system for embolization procedures as prescribed by a representative from Terumo or a Terumo-authorized distributor.

CONTRAINDICATIONS

Use of the Azur system is contraindicated in any of the following circumstances:

When superselective coil placement is not possible.

When end arteries lead directly to nerves.

When arteries supplying the lesion to be treated are notlarge enough to accept emboli.

When the A-V shunt is larger than the coil.

In the presence of severe atheromatous disease.

In the presence of vasospasm (or likely onset ofvasospasm).

POTENTIAL COMPLICATIONS

Potential complications include, but are not limited to: hematoma at the site of entry, vessel/aneurysm perforation, unintended parent artery occlusion, incomplete filling, vascular thrombosis, hemorrhage, ischemia, vasospasm, edema, coil migration or misplacement, premature or difficult coil detachment, clot formation, revascularization, post-embolization syndrome, and neurological deficits including stroke and possibly death.

The physician should be aware of these complications and instruct patients when indicated. Appropriate patient management should be considered.

REQUIRED ADDITIONAL ITEMS

Azur Detachment Controller

Appropriately sized catheter with double-braid support fordelivery of the AZUR system

Guidewires compatible with catheter

Rotating hemostatic Y valves (RHV)

Three-way stopcocks

Pressurized sterile saline drip

One-way stopcock

Stopwatch or timer

WARNINGS AND PRECAUTIONS

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

The Azur system is supplied sterile and non-pyrogenicunless package is opened or damaged.

This device is intended for single use only. Do not reuse,reprocess or resterilize. Reuse, reprocessing orresterilization may compromise the structural integrity of thedevice and/or lead to device failure which, in turn, may resultin patient injury, illness, or death. Reuse, reprocessing, orresterilization may also create a risk of contamination of thedevice and/or cause patient infection or cross-infection,including, but not limited to, the transmission of infectiousdisease(s) from one patient to another. Contamination of thedevice may lead to injury, illness or death of the patient.

Angiography is required for pre-embolization evaluation,operative control, and post-embolization follow up.

Do not advance the delivery pusher with excessive force.Determine the cause of any unusual resistance, remove theAzur system, and check for damage.

Advance and retract the Azur system slowly and smoothly.Remove the entire Azur system if excessive friction is noted.If excessive friction is noted with a second Azur system,check the catheter for damage or kinking.

The coil must be properly positioned in the vessel oraneurysm within the specified reposition time from the timethe device is first introduced into the catheter. If the coilcannot be positioned and detached within this time,simultaneously remove the device and the catheter.Positioning the device in a low-flow environment mayincrease the reposition time.

If repositioning is necessary, take special care to retract thecoil under fluoroscopy in a one-to-one motion with thedelivery pusher. If the coil does not move in a one-to-onemotion with the delivery pusher, or if repositioning is difficult,the coil may have become stretched and could possiblybreak. Gently remove and discard the entire device.

Due to the delicate nature of the coils, the tortuous vascularpathways that lead to certain lesions, and the varyingmorphologies of the vasculature, a coil may occasionallystretch while being maneuvered. Stretching is a precursor topotential coil breakage and migration.

If a coil must be retrieved from the vasculature afterdetachment, do not attempt to withdraw the coil with aretrieval device, such as a snare, into the delivery catheter.This could damage the coil and result in device separation.Remove the coil, catheter, and any retrieval device from thevasculature simultaneously.

Delivery of multiple coils is usually required to achieve thedesired occlusion of some vasculatures or lesions. Thedesired procedural endpoint is usually angiographicocclusion. The filling properties of the coils facilitateangiographic occlusion.

Tortuosity or complex vessel anatomy may affect accurateplacement of the coil.

The long-term effect of this product on extravascular tissueshas not been established so care should be taken to retainthis device in the intravascular space.

Coil Type Catheter I.D.

Reposition Time

inches mm

AZUR Detachable 35 0.041- 0.047 1.04 – 1.19 20 minutes

PM-00861

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Always ensure that at least two Azur Detachment Controllersare available before starting an Azur system procedure.

The coil cannot be detached with any power source otherthan an Azur Detachment Controller.

Do NOT place the delivery pusher on a bare metallicsurface.

Always handle the delivery pusher with surgical gloves.

Do NOT use in conjunction with radio frequency (RF)devices.

Figure 1 – Diagram of Azur System Setup

PREPARATION FOR USE

1. Refer to Figure 1 for the set-up diagram.2. Select a catheter with the appropriate inner diameter for coil

delivery.3. Attach a rotating hemostatic valve (RHV) to the hub of the

catheter. Attach a one-way stopcock to the side arm of the RHVand then connect the flush solution line to the stopcock. Iffluoroscopic roadmapping is being used, an appropriate guidecatheter with attached RHV and flush solution line must beincorporated as well.

4. Open the stopcock and flush the catheter with sterile flushsolution and then close the stopcock. To minimize the risk ofthromboembolic complications, it is critical that a continuousinfusion of appropriate sterile flush solution be maintained into thecatheter(s) and femoral sheath.

CATHETERIZATION OF THE LESION

5. Access the parent vessel or vascular lesion using standardinterventional procedures.

6. After the catheter has been positioned at the target site, removethe guidewire.

COIL SIZE SELECTION

7. Perform fluoroscopic road mapping.8. Measure and estimate the size of the lesion to be treated.9. For aneurysm occlusion, the diameter of the first and second coils

should never be less than the width of the aneurysm neck or thepropensity for the coils to migrate may be increased.

10. For vessel occlusion, select a coil size that is slightly larger thanthe vessel diameter.

11. Correct coil selection increases effectiveness and patient safety.Occlusive efficiency is, in part, a function of compaction andoverall coil mass. In order to choose the optimum coil for anygiven lesion, examine the pre-treatment angiograms. Theappropriate coil size should be chosen based upon angiographic

assessment of the diameter of the target or parent vessel, aneurysm dome and aneurysm neck.

PREPARATION OF THE AZUR SYSTEM FOR DELIVERY

Figure 2 – Azur Detachment Controller

12. Remove the Azur Detachment Controller from its protectivepackaging. Pull the white pull-tab from the side of the detachmentcontroller. Discard the pull-tab and place the detachmentcontroller in the sterile field. The Azur Detachment Controller ispackaged separately as a sterile device. Do not use any powersource other than the Azur Detachment Controller to detachthe coil. The Azur Detachment Controller is intended to beused on one patient. Do not attempt to re-sterilize orotherwise re-use the Azur Detachment Controller.

13. Prior to using the device, remove the proximal end of the deliverypusher from the packaging hoop. Use care to avoidcontaminating this end of the delivery pusher with foreignsubstances such as blood or contrast. Firmly insert the proximalend of the delivery pusher into the funnel section of the Azur

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Detachment Controller. See Figure 2. Do not push the detachment button at this time.

14. Wait three seconds and observe the indicator light on thedetachment controller.

If the green light does not appear or if a red light appears,replace the device.

If the light turns green, then turns off at any time during thethree-second observation, replace the device.

If the green light remains solid green for the entire three-second observation, continue using the device.

15. Hold the device just distal to the shrink-lock and pull the shrink-lock proximally to expose the tab on introducer sheath. SeeFigure 3.

Figure 3 - Pull Shrink Lock Proximally

16. Slowly advance the coil out of the introducer sheath and inspectthe coil for any irregularities or damage. If any damage to thecoil or delivery pusher is observed, DO NOT use the device.

17. With the distal end of the introducer sheath pointed downward,gently retract the implant back completely into the introducersheath about 1 to 2 cm.

INTRODUCTION AND DEPLOYMENT OF THE AZUR SYSTEM

18. Open the RHV on the catheter just enough to accept theintroducer sheath of the Azur system.

19. Insert the introducer sheath of the Azur system through the RHV.Flush the introducer until it is completely purged of air and salineflush exits the proximal end.

20. Seat the distal tip of the introducer sheath at the distal end of thecatheter hub and close the RHV lightly around the introducersheath to secure the RHV to the introducer.Do not over-tighten the RHV around the introducer sheath.Excessive tightening could damage the device.

21. Push the coil into the lumen of the catheter. Use caution to avoidcatching the coil on the junction between the introducer sheathand the hub of the catheter. Initiate timing using a stopwatchor timer at the moment the device enters the catheter.Detachment must occur within the specified reposition time.

22. Push the Azur system through the catheter until the proximal endof the delivery pusher meets the proximal end of the introducersheath. Loosen the RHV. Retract the introducer sheath just outof the RHV. Close the RHV around the delivery pusher. Slide theintroducer sheath completely off of the delivery pusher. Use carenot to kink the delivery system. To prevent premature hydrationof the Azur system, ensure that there is flow from the saline flush.

23. Discard the introducer sheath. The Azur system cannot be re-sheathed after introduction into the microcatheter.

24. At this time, fluoroscopic guidance should be initiated. Dependingon length of catheter used, fluoroscopy initiation may be delayedto minimize exposure.

25. Under fluoroscopic guidance, slowly advance the coil out the tip ofthe catheter. Continue to advance the coil into the lesion untiloptimal deployment is achieved. Reposition if necessary. If thecoil size is not suitable, remove and replace with another device.If undesirable movement of the coil is observed under fluoroscopyfollowing placement and prior to detachment, remove the coil andreplace with another more appropriately sized coil. Movement of

the coil may indicate that the coil could migrate once it is detached. DO NOT rotate the delivery pusher during or after delivery of the coil into the vasculature. Rotating the delivery pusher may result in a stretched coil or premature detachment of the coil from the delivery pusher, which could result in coil migration. Angiographic assessment should also be performed prior to detachment to ensure that the coil mass is not protruding into undesired vasculature.

26. Complete the deployment and any repositioning so that the coilwill be detached within the reposition time specified in Table 1.After the specified time, the swelling of the hydrophilic polymermay prevent passage through the catheter and damage the coil.If the coil cannot be properly positioned and detached withinthe specified time, simultaneously remove the device and thecatheter.

27. Advance the coil into the desired site until the radiopaque markeron the delivery pusher is aligned or slightly distal of catheter distaltip RO marker, positioning the detachment zone just outside thecatheter tip. See Figure 4.

28. Tighten the RHV to prevent movement of the coil.29. Verify repeatedly that the distal shaft of the delivery pusher is not

under stress before coil detachment. Axial compression ortension could cause the tip of the catheter to move during coildelivery. Catheter tip movement could cause the aneurysm orvessel to perforate.

Figure 4 – Position of Marker Bands for Detachment

DETACHMENT OF THE COIL

30. The Azur Detachment Controller is pre-loaded with battery powerand will activate when a delivery pusher is properly connected. Itis in a “power off” mode when no delivery pusher is attached. It isnot necessary to push the button on the side of the AzurDetachment Controller to activate it.

31. Verify that the RHV is firmly locked around the delivery pusherbefore attaching the Azur Detachment Controller to ensure thatthe coil does not move during the connection process.

32. Although the delivery pusher’s gold connectors are designed tobe compatible with blood and contrast, every effort should bemade to keep the connectors free of these items. If there appearsto be blood or contrast on the connectors, wipe the connectorswith sterile water or saline solution before connecting to the AzurDetachment Controller.

33. Connect the proximal end of the delivery pusher to the AzurDetachment Controller by firmly inserting the proximal end of thedelivery pusher into the funnel section of the Azur DetachmentController. See Figure 2.

34. When the Azur Detachment Controller is properly connected tothe delivery pusher, a single audible tone will sound and the lightwill turn green to signal that it is ready to detach the coil. If thedetachment button is not pushed within 30 seconds, the solidgreen light will slowly flash green. Both flashing green and solidgreen lights indicate that the device is ready to detach. If thegreen light does not appear, check to ensure that the connectionhas been made. If the connection is correct and no green lightappears, replace the Azur Detachment Controller.

35. Verify the coil position before pushing the detachment button.36. Push the detachment button. When the button is pushed, an

audible tone will sound and the light will flash green.37. At the end of the detachment cycle, three audible tones will sound

and the light will flash yellow three times. This indicates that thedetachment cycle is complete. If the coil does not detach duringthe detachment cycle, leave the Azur Detachment Controller

Pull shrink-lock proximally

Tab on introducer

sheath

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attached to the delivery pusher and attempt another detachment cycle when the light turns green.

38. The light will turn red after the number of detachment cyclesspecified on the Azur Detachment Controller labeling. DO NOTuse the Azur Detachment Controller if the light is red. Discard theAzur Detachment Controller and replace it with a new one whenthe light is red.

39. Verify detachment of the coil by first loosening the RHV valve,then pulling back slowly on the delivery system and verifying thatthere is no coil movement. If the implant did not detach, do notattempt to detach it more than two additional times. If it does notdetach after the third attempt, remove the delivery system.

40. After detachment has been confirmed, slowly retract and removethe delivery pusher. Advancing the delivery pusher once thecoil has been detached involves the risk of aneurysm orvessel rupture. Do NOT advance the delivery pusher once thecoil has been detached.

41. Verify the position of the coil angiographically.42. Additional coils may be deployed into the lesion as described

above. Prior to removing the catheter from the treatment site,place an appropriately sized guidewire completely through thecatheter lumen to ensure that no part of the last coil remainswithin the catheter.

The physician has the discretion to modify the coil deployment technique to accommodate the complexity and variation in embolization procedures. Any technique modifications must be consistent with the previously described procedures, warnings, precautions and patient safety information.

SPECIFICATIONS FOR AZUR DETACHMENT CONTROLLER

Output voltage: 8 ± 1 VDC

Cleaning, preventative inspection, and maintenance: TheAzur Detachment Controller is a single use device,preloaded with battery power, and packaged sterile. Nocleaning, inspection, or maintenance is required. If thedevice does not perform as described in the Detachmentsection of these Instructions, discard the Azur DetachmentController and replace it with a new unit.

The Azur Detachment Controller is a single use device. Donot reuse, reprocess or resterilize. Reuse, reprocessing orresterilization may compromise the structural integrity of thedevice and/or lead to device failure which, in turn, may resultin patient injury, illness, or death. Reuse, reprocessing, orresterilization may also create a risk of contamination of thedevice and/or cause patient infection or cross-infection,including, but not limited to, the transmission of infectiousdisease(s) from one patient to another. Contamination of thedevice may lead to injury, illness or death of the patient.

Batteries are pre-loaded into the Azur DetachmentControllers. Do not attempt to remove or replace thebatteries prior to use.

After use, dispose of the Azur Detachment Controller in amanner consistent with local regulations.

PACKAGING AND STORAGE

The Azur system is placed inside a protective, plastic dispenser hoop and packaged in a pouch and unit carton. The Azur system and dispenser hoop will remain sterile unless the package is opened, damaged, or the expiration date has passed. Store at a controlled room temperature in a dry place.

The Azur Detachment Controller is packaged separately in a protective pouch and carton. The Azur Detachment Controller has been sterilized; it will remain sterile unless the pouch is opened, damaged, or the expiration date has passed. Store at a controlled room temperature in a dry place.

SHELF LIFE

See the product label for the device shelf life. Do not use the device beyond the labeled shelf life.

MR INFORMATION

Non-clinical testing demonstrated that the coil implant is MR conditional. A patient can be scanned safely, immediately after placement under the following conditions:

Static magnetic field of 1.5 and 3 Tesla, with

Maximum spatial gradient field of 5000 Gauss/cm

Theoretically estimated maximum whole body average(WBA) specific absorption rate (SAR) of < 2W/kg(Normal Operating Mode)

MRI-Related Heating

Under the scan conditions above, and 15 minutes of continuous scanning, the coil implant is expected to produce a maximum temperature rise of 1.3°C

Image Artifact Information

MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the coil implant. Therefore, optimization of MR imaging parameters to compensate for the presence of this device may be necessary.

In non-clinical testing, the image artifact caused by the coil implant extends approximately 41.3mm in diameter and 21.3mm in height from the implant when imaged with a gradient and spin echo pulse sequence and a 3 Tesla MR system.

Terumo Corporation recommends that the patient register the MR conditions disclosed in this IFU with the MedicAlert Foundation or equivalent organization.

MATERIALS

The Azur system does not contain latex or PVC materials.

SYMBOLS

Lot Number

Order Number

Content

Sterilized Using Irradiation

Sterilized Using Ethylene Oxide

Do Not Reuse

Use-by Date

Date of Manufacture

Attention, Consult Accompanying Documents

Type BF Applied Part

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Power ON and OFF

CE Mark

Manufacturer

Authorized European Representative

MR Conditional

Non-pyrogenic

Upper limit of temperature

WARRANTY

Terumo warrants that reasonable care has been used in the design and manufacture of this device. This warranty is in lieu of and excludes all other warranties not expressly set forth herein, whether expressed or implied by operation of law or otherwise, including, but not limited to, any implied warranties of merchantability or fitness for particular purpose. Handling, storage, cleaning, and sterilization of the device as well as factors relating to the patient, diagnosis, treatment, surgical procedure, and other matters beyond Terumo’s control directly affect the device and the results obtained from its use. Terumo’s obligation under this warranty is limited to the repair or replacement of this device through its expiration date. Terumo shall not be liable for any incidental or consequential loss, damage or expense directly or indirectly arising from the use of this device. Terumo neither assumes, nor authorizes any other person to assume for it, any other or additional liability or responsibility in connection with this device. Terumo assumes no liability with respect to devices reused, reprocessed or resterilized and makes no warranties, expressed or implied, including, but not limited to, merchantability or fitness for intended use, with respect to such device.

Prices, specifications, and model availability are subject to change without notice.

© Copyright 2015 Terumo Corporation. All rights reserved.

Terumo and Azur are registered trademarks of Terumo Corporation.

MicroVention® is a registered trademark of MicroVention, Inc.

Manufacturer: MicroVention, Inc. 1311 Valencia Avenue Tustin, CA 92780 USA Tel: 714.247.8000 www.microvention.com

Distributed by: Terumo Medical Corporation 265 Davidson Avenue, Suite 320 Somerset, NJ 08873 Tel: (800) 862-4143

Authorized European Representative:

MicroVention Europe 30 bis, rue du Vieil Abreuvoir 78100 Saint-Germain-en-Laye France Tel: +33 (0)1 39 21 77 46 Fax: +33 (0)1 39 21 16 01

0297

PD111138 Rev. A Revised 2015-06

Azur Peripheral Coil System

Helical HydroCoil Embolization System (Detachable)


DEVICE DESCRIPTION

The Detachable Azur Peripheral Coil System (Azur system)consists of a coil implant attached to a delivery system. The coilsare platinum coils with an outer layer of hydrophilic polymer. Thedelivery pusher is powered by an Azur Detachment Controller toselectively detach the coils. The Azur Detachment Controller isprovided separately.

The Azur system is available in a broad range of coil diametersand lengths. The coil must be delivered only through a wire-reinforced microcatheter with the minimum inner diameterspecified.

Table 1

INDICATIONS FOR USE

The Azur system is intended to reduce or block the rate of bloodflow in vessels of the peripheral vasculature. It is intended for usein the interventional radiologic management of arteriovenousmalformations, arteriovenous fistulae, aneurysms, and otherlesions of the peripheral vasculature.

This device should only be used by physicians who haveundergone training in the use of the Azur system for embolizationprocedures as prescribed by a representative from Terumo

or a

Terumo-authorized distributor.

CONTRAINDICATIONS

Use of the Azur system is contraindicated in any of the followingcircumstances:








Potential complications include, but are not limited to: hematomaat the site of entry, vessel/aneurysm perforation, unintendedparent artery occlusion, incomplete filling, vascular thrombosis,hemorrhage, ischemia, vasospasm, edema, coil migration ormisplacement, premature or difficult coil detachment, clotformation, revascularization, post-embolization syndrome, andneurological deficits including stroke and possibly death.

The physician should be aware of these complications andinstruct patients when indicated. Appropriate patientmanagement should be considered.



Wire-reinforced microcatheter with distal tip RO marker,appropriately sized

Guide catheter compatible with microcatheter

Steerable guidewires compatible with microcatheter

2 rotating hemostatic Y valves (RHV)

1 three-way stopcock

Sterile saline and/or lactated Ringer’s injection


Steam source for optional pre-softening of implant

1 one-way stopcock

Stopwatch or timer







Advance and retract the Azur system slowly and smoothly.Remove the entire Azur system if excessive friction is noted.If excessive friction is noted with a second Azur system,check the microcatheter for damage or kinking.

The coil must be properly positioned in the vessel oraneurysm within three minutes from the time the device isfirst introduced into the microcatheter. If the coil cannot bepositioned and detached within this time, simultaneouslyremove the device and the microcatheter. Positioning thedevice in a low-flow environment may increase the repositiontime.



If a coil must be retrieved from the vasculature afterdetachment, do not attempt to withdraw the coil with aretrieval device, such as a snare, into the delivery catheter.This could damage the coil and result in device separation.Remove the coil, microcatheter, and any retrieval devicefrom the vasculature simultaneously.

Delivery of multiple coils is usually required to achieve thedesired occlusion of some vasculatures or lesions. Thedesired procedural endpoint is usually angiographicocclusion. The filling properties of the coils facilitateangiographic occlusion and reduce the need to tightly packwith numerous coils.




Coil Type

Minimum Microcatheter I.D. Reposition

Time inches mm

Azur Detachable 18 0.021 0.53 3 minutes

Azur Detachable 35 0.038 0.97 3 minutes

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PREPARATION FOR USE

1. Refer to Figure 1 for the set-up diagram.2. Attach a rotating hemostatic valve (RHV) to the hub of the guiding

catheter. Attach a 3-way stopcock to the side arm of the RHVand then connect a line for continuous infusion of flush solution.

3. Attach a second RHV to the hub of the microcatheter. Attach a 1-way stopcock to the sidearm of the second RHV and connect theflush solution line to the stopcock.

4. Open the stopcock and flush the microcatheter with sterile flushsolution and then close the stopcock. To minimize the risk ofthromboembolic complications, it is critical that a continuousinfusion of appropriate sterile flush solution be maintained into theguide catheter, the femoral sheath and the microcatheter.


5. Using standard interventional procedures, access the vessel witha guide catheter. The guide catheter should have an innerdiameter (ID) large enough to allow for contrast injection while themicrocatheter is in place. This will allow for fluoroscopic roadmapping during the procedure.

6. Select a microcatheter with the appropriate inner diameter. Afterthe microcatheter has been positioned inside the lesion, removethe guidewire.

COIL SIZE SELECTION

7. Perform fluoroscopic road mapping.8. Measure and estimate the size of the lesion to be treated.9. At the discretion of the physician, one or more framing coils

(platinum 3D coils) may be used to establish an initial framework.

10. For aneurysm occlusion, the diameter of the first and second coilsshould never be less than the width of the aneurysm neck or thepropensity for the coils to migrate may be increased. Thediameter of the first helical coil should be 1-2 mm smaller than theinitial basket coil or aneurysm dome.


12. Correct coil selection increases effectiveness and patient safety.Occlusive efficiency is, in part, a function of compaction andoverall coil mass. In order to choose the optimum coil for anygiven lesion, examine the pre-treatment angiograms. Theappropriate coil size should be chosen based upon angiographicassessment of the diameter of the target or parent vessel,aneurysm dome and aneurysm neck. NOTE: The coils include anouter layer of a hydrophilic polymer. The primary coil diameterand the secondary coil diameter (dimension ‘A’ on the packagelabel) will increase by approximately 0.5 mm following hydration.


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13. Remove the Azur Detachment Controller from its protectivepackaging. Pull the white pull-tab from the side of the detachmentcontroller. Discard the pull-tab and place the detachmentcontroller in the sterile field. The Azur Detachment Controller ispackaged separately as a sterile device. Do not use any powersource other than the Azur Detachment Controller to detachthe coil. The Azur Detachment Controller is intended to beused on one patient. Do not attempt to re-sterilize orotherwise re-use the Azur Detachment Controller.

14. Prior to using the device, remove the proximal end of the deliverypusher from the packaging hoop. Use care to avoidcontaminating this end of the delivery pusher with foreignsubstances such as blood or contrast. Firmly insert the proximalend of the delivery pusher into the funnel section of the AzurDetachment Controller. See Figure 2. Do not push thedetachment button at this time.







17. Slowly advance the coil out of the introducer sheath and inspectthe coil for any irregularities or damage. If any damage to thecoil or delivery pusher is observed, DO NOT use the device.

18. If pre–softening of the Azur implant is desired, advance it out ofthe distal end of the introducer sheath and immerse it in warmsterile saline or warm lactated Ringer’s injection. Alternatively,hold it in a flow of steam until it curls, usually about five to tenseconds. When using steam, appropriate sterile technique shouldbe used. In addition, the Azur system may be used without pre-softening.

19. With the distal end of the introducer sheath pointed downwardand the implant still in the warm saline, warm lactated Ringer’s

injection or flow of steam, gently retract the implant backcompletely into the introducer sheath about 1 to 2 cm.


20. Open the RHV on the microcatheter just enough to accept theintroducer sheath of the Azur system.


22. Seat the distal tip of the introducer sheath at the distal end of themicrocatheter hub and close the RHV lightly around theintroducer sheath to secure the RHV to the introducer.Do not over-tighten the RHV around the introducer sheath.Excessive tightening could damage the device.

23. Push the coil into the lumen of the microcatheter. Use caution toavoid catching the coil on the junction between the introducersheath and the hub of the microcatheter. Initiate timing using astopwatch or timer at the moment the device enters themicrocatheter. Detachment must occur within the specifiedreposition time.

24. Push the Azur system through the microcatheter until the proximalend of the delivery pusher meets the proximal end of theintroducer sheath. Loosen the RHV. Retract the introducersheath just out of the RHV. Close the RHV around the deliverypusher. Slide the introducer sheath completely off of the deliverypusher. Use care not to kink the delivery system. To preventpremature hydration of the Azur system, ensure that there is flowfrom the saline flush.


26. At this time, fluoroscopic guidance should be initiated. Dependingon length of microcatheter used, fluoroscopy initiation may bedelayed to minimize exposure.

27. Under fluoroscopic guidance, slowly advance the coil out the tip ofthe microcatheter. Continue to advance the coil into the lesionuntil optimal deployment is achieved. Reposition if necessary. Ifthe coil size is not suitable, remove and replace with anotherdevice. If undesirable movement of the coil is observed underfluoroscopy following placement and prior to detachment, removethe coil and replace with another more appropriately sized coil.Movement of the coil may indicate that the coil could migrate onceit is detached. DO NOT rotate the delivery pusher during or afterdelivery of the coil into the vasculature. Rotating the deliverypusher may result in a stretched coil or premature detachment ofthe coil from the delivery pusher, which could result in coilmigration. Angiographic assessment should also be performedprior to detachment to ensure that the coil mass is not protrudinginto undesired vasculature.

28. Complete the deployment and any repositioning so that the coilwill be detached within the reposition time specified in Table 1.After the specified time, the swelling of the hydrophilic polymermay prevent passage through the microcatheter and damage thecoil. If the coil cannot be properly positioned and detachedwithin the specified time, simultaneously remove the deviceand the microcatheter.

29. Advance the coil into the desired site until the radiopaque markeron the delivery pusher is aligned or slightly distal of microcatheterdistal tip RO marker, positioning the detachment zone just outsidethe microcatheter tip. See Figure 4.


under stress before coil detachment. Axial compression ortension could cause the tip of the microcatheter to move duringcoil delivery. Catheter tip movement could cause the aneurysmor vessel to perforate.


Tab on introducersheath

- 4 -


To minimize the potential risk of aneurysm or vessel perforationDO NOT advance the distal end of the delivery system past thedistal tip of the microcatheter.









and the light will flash yellow three times. This indicates that thedetachment cycle is complete. If the coil does not detach duringthe detachment cycle, leave the Azur Detachment Controllerattached to the delivery pusher and attempt another detachmentcycle when the light turns green.



42. After detachment has been confirmed, slowly retract and removethe delivery pusher. Advancing the delivery pusher once thecoil has been detached involves the risk of aneurysm or vessel rupture. Do NOT advance the delivery pusher once the coil has been detached.

43. Verify the position of the coil angiographically through the guidecatheter.

44. Additional coils may be deployed into the lesion as describedabove. Prior to removing the microcatheter from the treatmentsite, place an appropriately sized guidewire completely through

the microcatheter lumen to ensure that no part of the last coilremains within the microcatheter.

The physician has the discretion to modify the coil deploymenttechnique to accommodate the complexity and variation inembolization procedures. Any technique modifications must beconsistent with the previously described procedures, warnings,precautions and patient safety information.








The Azur system is placed inside a protective, plastic dispenserhoop and packaged in a pouch and unit carton. The Azur systemand dispenser hoop will remain sterile unless the package isopened, damaged, or the expiration date has passed. Store at acontrolled room temperature in a dry place.

The Azur Detachment Controller is packaged separately in aprotective pouch and carton. The Azur Detachment Controllerhas been sterilized; it will remain sterile unless the pouch isopened, damaged, or the expiration date has passed. Store at acontrolled room temperature in a dry place.

SHELF LIFE

See the product label for the device shelf life. Do not use thedevice beyond the labeled shelf life.

MR INFORMATION

The coil implant has been determined to be MR conditionalaccording to the terminology specified in the American Society forTesting and Materials (ASTM) International, Designation: F2503-08.

Non-clinical testing demonstrated that the coil implant is MRconditional. A patient can be scanned safely, immediately afterplacement under the following conditions:

Static magnetic field of 3 Tesla or less

Maximum spatial gradient field of 720 Gauss/cm or less

MRI-Related Heating

In non-clinical testing, the coil implant produced a maximumtemperature rise of 1.7°C during MRI performed for 15 minutes of

- 5 -

scanning in the 3 Tesla (3-Tesla/128-MHz, Excite, HDx, Software14X.M5, General Electric Healthcare, Milwaukee, WI) MR system.

Therefore, the MRI-related heating experiments for the coilimplant at 3 Tesla using a transmit/receive RF body coil at an MRsystem reported whole body averaged SAR of 2.9 W/kg (i.e.,associated with a calorimetry measured whole body averagedvalue of 2.7 W/kg) indicated that the greatest amount of heatingthat occurred in association with these specific conditions wasequal to or less than 1.7°C.


MR image quality may be compromised if the area of interest is inthe exact same area or relatively close to the position of the coilimplant. Therefore, optimization of MR imaging parameters tocompensate for the presence of this device may be necessary.

Terumo Corporation recommends that the patient register the MRconditions disclosed in this IFU with the MedicAlert Foundation orequivalent organization.

MATERIALS


SYMBOLS

Lot Number

Order Number

Content



Do Not Reuse

Use-by Date

Date of Manufacture



Power ON and OFF

CE Mark

Manufacturer


MR Conditional

Non-pyrogenic


WARRANTY

Terumo warrants that reasonable care has been used in thedesign and manufacture of this device. This warranty is in lieu ofand excludes all other warranties not expressly set forth herein,whether expressed or implied by operation of law or otherwise,including, but not limited to, any implied warranties ofmerchantability or fitness for particular purpose. Handling,storage, cleaning, and sterilization of the device as well as factorsrelating to the patient, diagnosis, treatment, surgical procedure,and other matters beyond Terumo’s control directly affect the device and the results obtained from its use. Terumo’s obligationunder this warranty is limited to the repair or replacement of thisdevice through its expiration date. Terumo shall not be liable forany incidental or consequential loss, damage or expense directlyor indirectly arising from the use of this device. Terumo neitherassumes, nor authorizes any other person to assume for it, anyother or additional liability or responsibility in connection with thisdevice. Terumo assumes no liability with respect to devicesreused, reprocessed or resterilized and makes no warranties,expressed or implied, including, but not limited to, merchantabilityor fitness for intended use, with respect to such device.

Prices, specifications, and model availability are subject tochange without notice.



MicroVention® and HydroCoil

® are registered trademarks of MicroVention, Inc.

Manufacturer:

MicroVention, Inc.1311 Valencia AvenueTustin, CA 92780 USA Tel: 714.247.8000www.microvention.com

Distributed by:

Terumo Medical Corporation2101 Cottontail Lane Somerset, NJ 08873 Tel: (800) 862-4143


MicroVention Europe30 bis, rue du Vieil Abreuvoir78100 Saint-Germain-en-LayeFranceTel: +33 (0)1 39 21 77 46Fax: +33 (0)1 39 21 16 01

0297

PD110088 Rev. B Revised 2012-11

Pulse Sequence: T1-SE T1-SE GRE GRE Plane Orientation: Parallel Perpendicular Parallel Perpendicular

Signal Void Size: 511 mm2

80 mm2

633 mm2

179 mm2

- 1 -

Azur Peripheral Coil System Helical HydroCoil® Embolization System

(Pushable) Instructions for Use

DEVICE DESCRIPTION

The Pushable Azur Peripheral Coil System (Azur system) consists of acoil implant packaged in a coil introducer along with an introducer stylet.The coil is platinum-based with an outer layer of hydrogel polymer.

The Azur system is available in helical 18-system and helical 35-systemconfigurations. Both configurations are available in a broad range ofsecondary diameters and lengths to meet the needs of the physician.Each system must be delivered through a microcatheter or catheterwithin the specified ID range, using a specified guidewire size.

System Catheter/Microcatheter ID

inches mm

18-system 0.021 – 0.022 0.53 – 0.56

35-system 0.041 – 0.047 1.04 – 1.19

System Guidewire OD

inches mm

18-system 0.018 0.46

35-system 0.035 0.89

INDICATIONS FOR USE

The Azur system is intended to reduce or block the rate of blood flow invessels of the peripheral vasculature. It is intended for use in theinterventional radiologic management of arteriovenous malformations,arteriovenous fistulae, aneurysms, and other lesions of the peripheralvasculature.

This device should only be used by physicians who have undergonetraining in the use of the Azur system for embolization procedures asprescribed by a representative from Terumo

or a Terumo-authorized

distributor.

CONTRAINDICATIONS




When arteries supplying the lesion to be treated are not largeenough to accept emboli.



In the presence of vasospasm (or likely onset of vasospasm).


Potential complications include, but are not limited to: hematoma at thesite of entry, vessel/aneurysm perforation, unintentional occlusion of theparent artery, incomplete filling, emboli, hemorrhage, ischemia,vasospasm, edema, coil migration or misplacement, clot formation,revascularization, post-embolization syndrome, and neurological deficitsincluding stroke and possibly death.


Appropriately-sized catheter/microcatheter (with wire reinforcementrequired for delivery through tortuous vasculature)

Steerable guidewire compatible with coil system and deliverycatheter/microcatheter

Rotating hemostatic Y valve (RHV)

Sterile saline


One-way stopcock

1cc syringe


Federal law (USA) restricts this device to sale by or on the order of a physician.

The Azur system is sterile and non-pyrogenic unless the unitpackage is opened or damaged.

The Azur system is intended for single use only. Do not reuse,reprocess or resterilize. Reuse, reprocessing or resterilization maycompromise the structural integrity of the device and/or lead todevice failure which, in turn, may result in patient injury, illness, ordeath. Reuse, reprocessing, or resterilization may also create arisk of contamination of the device and/or cause patient infection orcross-infection, including, but not limited to, the transmission ofinfectious disease(s) from one patient to another. Contamination ofthe device may lead to injury, illness or death of the patient.

Angiography is required for pre-embolization evaluation, operativecontrol, and post-embolization follow up. Fluoroscopicroadmapping is recommended to achieve optimal deviceplacement.

Always inspect the Azur system prior to both preparation andinsertion to ensure that the coil has not shifted within the introduceror migrated into the introducer caps. If the coil is not secure withinthe introducer prior to both the preparation and introductionprocesses, damage may result.

Hydration of the Azur system prior to use is mandatory. A 3-

minute hydration period is required to soften the coil. Failure tohydrate may result in the coil not taking its secondary shape, whichcan result in deployment away from the intended location,migration, or protrusion outside the delivery location.

The coil must be delivered through a compatibly-sized catheter ormicrocatheter with a PTFE inner surface coating using acompatibly-sized guidewire. Failure to correctly size the deliverysystem may result in damage to the device and necessitateremoval of both the device and delivery catheter from the patient.

Always select a wire-reinforced delivery catheter/microcatheterwhen delivering the coil through highly tortuous vasculature. Non-reinforced catheters may ovalize under such circumstances,potentially resulting in coil damage and necessitating removal ofboth the device and delivery catheter from the patient.

Do not use a syringe to deliver the coil. The coil is intended to bedelivered using a compatible guidewire only. Delivery via syringeinjection may result in the coil not taking its secondary shape,which can result in deployment away from the intended location,migration, or protrusion outside the delivery location.

Do not advance the coil with excessive force. If unusual resistanceis noted during advancement, determine its cause beforeproceeding by verifying the appropriate delivery catheter andguidewire are being used, and that both are free from damage andkinking. If necessary, replace the delivery catheter, coil, and/orguidewire before proceeding.

The coil is not retractable or repositionable. If a coil must beretrieved from the vasculature after deployment, do not attempt towithdraw the coil with a retrieval device, such as a snare, into thedelivery catheter. This could damage the coil and result in deviceseparation. Remove the coil, microcatheter, and any retrievaldevice from the vasculature simultaneously.

If the coil and/or pushing guidewire get stuck within the deliverycatheter lumen, do not continue advancing. Remove the catheter,and replace the catheter, coil, and/or guidewire when necessary.

Delivery of multiple coils is generally required to achieve thedesired occlusion of some vessels, aneurysms, and vascularlesions. The desired procedural endpoint is angiographicocclusion. The filling properties of the coil facilitate angiographicocclusion and reduce the need to tightly pack. Multipleembolization procedures may be required to achieve the desiredocclusion of some vessels/vascular lesions.

- 2 -


The long-term effect of this product on extravascular tissues hasnot been established. Care should be taken to retain the device inthe intravascular space.

Always advance an appropriately-sized guidewire through thedelivery catheter after deployment to ensure that no part of the coilremains within the catheter prior to delivering the next coil orremoving the catheter from the patient.

Diagram of Azur System Setup

PREPARATION FOR USE

1. Refer to the setup diagram.

2. Select the catheter or microcatheter to be used for coildelivery. Select a compatible pushing guidewire.

3. Attach an RHV to the hub of the deliverycatheter/microcatheter. Attach a one-way stopcock to theside arm of the RHV and connect the flush solution line tothe stopcock. (If fluoroscopic roadmapping is being used, anappropriate guide catheter with attached RHV and flushsolution line must be incorporated as well.)

4. Open the stopcock and flush the delivery catheter with sterileflush solution. Close the stopcock. To minimize the risk ofthromboembolic complications, it is critical that a continuousinfusion of appropriate sterile flush solution be maintainedinto the delivery catheter (and femoral sheath, if present).


5. Access the parent vessel or vascular structure usingstandard interventional procedures.

6. Position the delivery catheter for pushable coil deploymentas close to the target lesions as possible, using standardtechnique. Remove the guidewire, if used.

COIL SIZE SELECTION

7. Measure or estimate the size of the vessel or lesion to betreated.

8. Select appropriately sized coils. The diameter of the firstand second coils placed should never be less than the diameter of the vessel to be treated or less than the neckwidth of the aneurysm to be treated, or the propensity for thecoils to migrate may be increased. For vessel occlusion, it issuggested that the diameter of the initial coil placed beslightly larger than the actual vessel diameter to preventdisplacement or migration. For aneurysm treatment, coils

placed within the aneurysm sac must not be larger than thedome size, or protrusion of the coil from the sac may result.

9. Correct coil selection increases effectiveness and patientsafety. Occlusive efficiency is, in part, a function ofcompaction and overall coil mass. In order to choose theoptimum coil for any given lesion, examine the pre-treatmentangiograms. The appropriate coil size should be chosenbased upon angiographic assessment of the treatment site.For vessel occlusion, the diameter of the vessel must beconsidered. In the case of aneurysms, diameter of theparent vessel, aneurysm dome size, and aneurysm neckwidth must be considered.

NOTE: The coil has an outer layer consisting of a hydrophilicpolymer. As a result, the secondary coil diameter(dimension ‘A’ on the package label) will increase byapproximately 0.5 mm following full hydration (approx. 20minutes).

PREPARATION FOR DELIVERY

10. Remove both the coil (in its introducer) and stylet from theprotective pouch.

11. Verify the cap is present and secure on the distal end of theintroducer and that the introducer is free from damage. Ifany damage is observed, DO NOT use the system.

12. Verify the coil is properly positioned in the introducer. If thecoil has migrated proximally into the introducer hub, gentlytap the distal end of the introducer onto a flat surface untilthe proximal end is no longer visible in the hub. If it hasmigrated distally into the cap, gently tap the proximal end ofthe introducer onto a flat surface until the distal end returnsto the tube.

13. Remove the proximal cap from the introducer hub.

14. Fill a 1-cc syringe with saline. Connect the syringe to theintroducer hub. Hold the introducer in a level position andslowly and gently inject saline until saline emerges from thevented distal cap. Allow the coil to remain in the introducerfor 3 minutes, leaving the syringe attached. This helps

- 3 -

ensure coil hydration and softening, which allows the coil toquickly take its secondary shape upon delivery. Verify thatthe coil has not migrated into the hub or distal cap prior toproceeding.

NOTE: Do not overpressurize the introducer during hydration by holding the introducer upright or injecting too quickly. Doing so may result in migration of the coil into the distal cap or premature removal of the cap, which may result in coil damage.


NOTE: Do not proceed with coil introduction and deployment until after completion of the 3-minute saline hydration period.

15. Open the RHV on the delivery catheter just enough to acceptthe introducer.

16. Verify that the syringe is still attached to the introducer.Remove the distal cap and insert the introducer through theRHV. Seat the distal tip of the introducer in the ID of thedelivery catheter hub and lightly close the RHV around theintroducer to secure it in place. The introducer must beseated in the hub prior to tightening the RHV. If theintroducer is not seated, the coil may get caught in theresulting gap, potentially causing damage and inability to complete insertion.

17. Remove the syringe from the introducer hub andimmediately insert the stylet. Using the stylet, push the coilthrough the introducer, RHV, and catheter hub, into thelumen of the delivery catheter. Advance the styletcompletely, until its shaped end seats on the introducer hub.This will ensure that the coil has been fully inserted into thecatheter lumen. If the coil does not advance easily into thecatheter lumen, rotate the introducer ½ turn while keeping itseated within the catheter hub, and advance the coil with thestylet. Use caution to avoid catching the coil on the junctionbetween the introducer and the delivery catheter hub. Oncethe coil has been introduced into the delivery catheter lumen,no more than 3 minutes must pass prior to coil delivery.

18. Remove and discard the coil introducer and stylet. Toprevent premature expansion of the coil, ensure that there iscontinuous intralumenal flow from the saline flush.

19. Insert an appropriately-sized pushing guidewire through theRHV. Using the guidewire, slowly advance the coil throughthe delivery catheter until it exits the catheter tip. Continueto slowly advance the coil into the lesion or vessel, adjustingcatheter positioning as necessary, until optimal deploymentis achieved. Complete the deployment within 3 minutes.After 3 minutes, swelling of the hydrophilic polymer mayprevent passage through the delivery catheter and result indamage to the coil.

NOTE: It is recommended to secure the catheter in placeduring coil advancement and delivery to prevent the cathetertip from moving away from the intended delivery location.

20. Once the coil has been deployed and prior to removing thedelivery catheter, advance the guidewire through thecatheter tip to verify that no part of the coil remains within thecatheter lumen.

The physician has the discretion to modify the coil deploymenttechnique to accommodate the complexity and variation inembolization procedures. Any technique modifications must beconsistent with the previously-described procedures, warnings,precautions, and patient safety information.


The coil is provided in a capped coil introducer, and, together witha stylet, is packaged inside a protective pouch. There are threepouched devices in each unit carton. The coil, the coil introducer,and the stylet all remain sterile unless the package is opened,damaged, or the expiration date has passed. Store at acontrolled room temperature in a dry place.

SHELF LIFE

See the product label for device shelf life. Do not use the devicebeyond the labeled shelf life.

MR INFORMATION





MRI-Related Heating

In non-clinical testing, the coil implant produced a maximumtemperature rise of 1.7°C during MRI performed for 15 minutes ofscanning in the 3 Tesla (3-Tesla/128-MHz, Excite, HDx, Software14X.M5, General Electric Healthcare, Milwaukee, WI) MR system.



MR image quality may be compromised if the area of interest is inthe exact same area or relatively close to the position of the coilimplant. Therefore, optimization of MR imaging parameters tocompensate for the presence of this device may be necessary.


MATERIALS


SYMBOLS

Lot Number

Order Number

Content


Do Not Reuse

Use-by Date



80 mm2

633 mm2

179 mm2

- 4 -

Date of Manufacture


CE Mark

Manufacturer


MR Conditional

Non-pyrogenic


WARRANTY

Terumo warrants that reasonable care has been used in thedesign and manufacture of this device. This warranty is in lieu ofand excludes all other warranties not expressly set forth herein,whether expressed or implied by operation of law or otherwise,including, but not limited to, any implied warranties ofmerchantability or fitness for particular purpose. Handling,storage, cleaning and sterilization of the device as well as factorsrelating to the patient, diagnosis, treatment, surgical procedureand other matters beyond Terumo’s control directly affect thedevice and the results obtained from its use. Terumo’s obligationunder this warranty is limited to the repair or replacement of thisdevice through its expiration date. Terumo shall not be liable forany incidental or consequential loss, damage or expense directlyor indirectly arising from the use of this device. Terumo neitherassumes, nor authorizes any other person to assume for it, anyother or additional liability or responsibility in connection with thisdevice. Terumo assumes no liability with respect to devicesreused, reprocessed or resterilized and makes no warranties,expressed or implied, including, but not limited to, merchantabilityor fitness for intended use, with respect to such device.

Prices, specifications and model availability are subject to changewithout notice.


Terumo® and Azur

are registered trademarks of Terumo Corporation.

MicroVention® and HydroCoil

® are registered trademarks of MicroVention, Inc.

Manufacturer: MicroVention, Inc.1311 Valencia AvenueTustin, CA 92780 USA Tel: (714) 247-8000www.microvention.com

Distributed by:

Terumo Medical Corporation 2101 Cottontail Lane Somerset, NJ 08873 Tel: (800) 862-4143


MicroVention Europe30 bis, rue du Vieil Abreuvoir78100 Saint-Germain-en-Laye

France

Tel: +33 (0)1 39 21 77 46Fax: +33 (0)1 39 21 16 01

0297 PD110090 Rev. A

Revised 2012-11

Azur Peripheral Coil System Framing Coil (Detachable)


DEVICE DESCRIPTION

The Detachable Azur Peripheral Coil System Framing Coil (Azursystem) consists of a coil implant attached to a delivery system.The coils are platinum coils. The delivery pusher is powered byan Azur Detachment Controller to selectively detach the coils.The Azur Detachment Controller is provided separately.

The Azur system is available in a broad range of coil diametersand lengths. The coil must be delivered only through a wire-reinforced microcatheter with the minimum inner diameterspecified.

Table 1

INDICATIONS FOR USE

The Azur system is intended to reduce or block the rate of bloodflow in vessels of the peripheral vasculature. It is intended for usein the interventional radiologic management of arteriovenousmalformations, arteriovenous fistulae, aneurysms, and otherlesions of the peripheral vasculature.

This device should only be used by physicians who haveundergone training in the use of the Azur system for embolizationprocedures as prescribed by a representative from Terumo

or a

Terumo-authorized distributor.

CONTRAINDICATIONS









Potential complications include, but are not limited to: hematomaat the site of entry, vessel/aneurysm perforation, unintendedparent artery occlusion, incomplete filling, vascular thrombosis,hemorrhage, ischemia, vasospasm, edema, coil migration ormisplacement, premature or difficult coil detachment, clotformation, revascularization, post-embolization syndrome, andneurological deficits including stroke and possibly death.

The physician should be aware of these complications andinstruct patients when indicated. Appropriate patientmanagement should be considered.



Wire-reinforced microcatheter with distal tip RO marker,appropriately sized

Guide catheter compatible with microcatheter

Steerable guidewires compatible with microcatheter

2 rotating hemostatic Y valves (RHV)

1 three-way stopcock

Sterile saline


1 one-way stopcock







Advance and retract the Azur system slowly and smoothly.Remove the entire Azur system if excessive friction is noted.If excessive friction is noted with a second Azur system,check the microcatheter for damage or kinking.



If a coil must be retrieved from the vasculature afterdetachment, do not attempt to withdraw the coil with aretrieval device, such as a snare, into the delivery catheter.This could damage the coil and result in device separation.Remove the coil, microcatheter, and any retrieval devicefrom the vasculature simultaneously.

Delivery of multiple coils is usually required to achieve thedesired occlusion of some vasculatures or lesions. Thedesired procedural endpoint is usually angiographicocclusion. The filling properties of the coils facilitateangiographic occlusion and reduce the need to tightly packwith numerous coils.


Always advance an appropriately sized guidewire throughthe microcatheter after detaching the coil and removing thepusher to ensure that no part of the coil remains within themicrocatheter.







Coil Type

Minimum Microcatheter I.D.

inches mm

Azur Detachable 18 0.021 0.53

Azur Detachable 35 0.038 0.97

- 2 -


PREPARATION FOR USE

1. Refer to Figure 1 for the set-up diagram.2. Attach a rotating hemostatic valve (RHV) to the hub of the guiding

catheter. Attach a 3-way stopcock to the side arm of the RHVand then connect a line for continuous infusion of flush solution.

3. Attach a second RHV to the hub of the microcatheter. Attach a 1-way stopcock to the sidearm of the second RHV and connect theflush solution line to the stopcock.

4. Open the stopcock and flush the microcatheter with sterile flushsolution and then close the stopcock. To minimize the risk ofthromboembolic complications, it is critical that a continuousinfusion of appropriate sterile flush solution be maintained into theguide catheter, the femoral sheath and the microcatheter.


5. Using standard interventional procedures, access the vessel witha guide catheter. The guide catheter should have an innerdiameter (ID) large enough to allow for contrast injection while themicrocatheter is in place. This will allow for fluoroscopic roadmapping during the procedure.

6. Select a microcatheter with the appropriate inner diameter. Afterthe microcatheter has been positioned inside the lesion, removethe guidewire.

COIL SIZE SELECTION

7. Perform fluoroscopic road mapping.8. Measure and estimate the size of the lesion to be treated.9. At the discretion of the physician, one or more Azur Framing Coils

(platinum 3D coils) may be used to establish an initial framework.10. For aneurysm occlusion, the diameter of the first and second coils

should never be less than the width of the aneurysm neck or thepropensity for the coils to migrate may be increased.


12. Correct coil selection increases effectiveness and patient safety.Occlusive efficiency is, in part, a function of compaction andoverall coil mass. In order to choose the optimum coil for anygiven lesion, examine the pre-treatment angiograms. Theappropriate coil size should be chosen based upon angiographicassessment of the diameter of the target or parent vessel,aneurysm dome and aneurysm neck.



13. Remove the Azur Detachment Controller from its protectivepackaging. Pull the white pull-tab from the side of the detachmentcontroller. Discard the pull-tab and place the detachment

- 3 -

controller in the sterile field. The Azur Detachment Controller ispackaged separately as a sterile device. Do not use any powersource other than the Azur Detachment Controller to detach the coil. The Azur Detachment Controller is intended to be used on one patient. Do not attempt to re-sterilize or otherwise re-use the Azur Detachment Controller.

14. Prior to using the device, remove the proximal end of the deliverypusher from the packaging hoop. Use care to avoidcontaminating this end of the delivery pusher with foreignsubstances such as blood or contrast. Firmly insert the proximalend of the delivery pusher into the funnel section of the AzurDetachment Controller. See Figure 2. Do not push thedetachment button at this time.







17. Slowly advance the coil implant out of the introducer sheath andinspect the coil for any irregularities or damage. If any damageto the coil or delivery pusher is observed, DO NOT use thedevice.


18. Open the RHV on the microcatheter just enough to accept theintroducer sheath of the Azur system.


20. Seat the distal tip of the introducer sheath at the distal end of themicrocatheter hub and close the RHV lightly around theintroducer sheath to secure the RHV to the introducer.Do not over-tighten the RHV around the introducer sheath.Excessive tightening could damage the device.

21. Push the coil into the lumen of the microcatheter. Use caution toavoid catching the coil on the junction between the introducersheath and the hub of the microcatheter.

22. Push the Azur system through the microcatheter until the proximalend of the delivery pusher meets the proximal end of theintroducer sheath. Loosen the RHV. Retract the introducersheath just out of the RHV. Close the RHV around the deliverypusher. Slide the introducer sheath completely off of the deliverypusher. Use care not to kink the delivery system.

23. At this time, fluoroscopic guidance should be initiated. Dependingon length of microcatheter used, fluoroscopy initiation may bedelayed to minimize exposure.

24. Under fluoroscopic guidance, slowly advance the coil out the tip ofthe microcatheter. Continue to advance the coil into the lesionuntil optimal deployment is achieved. Reposition if necessary. If

the coil size is not suitable, remove and replace with anotherdevice. If undesirable movement of the coil is observed underfluoroscopy following placement and prior to detachment, removethe coil and replace with another more appropriately sized coil.Movement of the coil may indicate that the coil could migrate onceit is detached. DO NOT rotate the delivery pusher during or afterdelivery of the coil into the vasculature. Rotating the deliverypusher may result in a stretched coil or premature detachment ofthe coil from the delivery pusher, which could result in coilmigration. Angiographic assessment should also be performedprior to detachment to ensure that the coil mass is not protrudinginto undesired vasculature.

25. Advance the coil into the desired site until the radiopaque markeron the delivery pusher is aligned or slightly distal of microcatheterdistal tip RO marker, positioning the detachment zone just outsidethe microcatheter tip. See Figure 4.


under stress before coil detachment. Axial compression ortension could cause the tip of the microcatheter to move duringcoil delivery. Catheter tip movement could cause the aneurysmor vessel to perforate.


To minimize the potential risk of aneurysm or vessel perforationDO NOT advance the distal end of the delivery system past thedistal tip of the microcatheter.









and the light will flash yellow three times. This indicates that thedetachment cycle is complete. If the coil does not detach duringthe detachment cycle, leave the Azur Detachment Controller


Tab on introducersheath

- 4 -

attached to the delivery pusher and attempt another detachmentcycle when the light turns green.



38. After detachment has been confirmed, slowly retract and removethe delivery pusher. Advancing the delivery pusher once thecoil has been detached involves the risk of aneurysm orvessel rupture. Do NOT advance the delivery pusher once thecoil has been detached.

39. Verify the position of the coil angiographically through the guidecatheter.

40. Additional coils may be deployed into the lesion as describedabove. Prior to removing the microcatheter from the treatmentsite, place an appropriately sized guidewire completely throughthe microcatheter lumen to ensure that no part of the last coilremains within the microcatheter.

The physician has the discretion to modify the coil deploymenttechnique to accommodate the complexity and variation inembolization procedures. Any technique modifications must beconsistent with the previously described procedures, warnings,precautions and patient safety information.








The Azur system is placed inside a protective, plastic dispenserhoop and packaged in a pouch and unit carton. The Azur systemand dispenser hoop will remain sterile unless the package isopened, damaged, or the expiration date has passed. Store at acontrolled room temperature in a dry place.

The Azur Detachment Controller is packaged separately in aprotective pouch and carton. The Azur Detachment Controllerhas been sterilized; it will remain sterile unless the pouch isopened, damaged, or the expiration date has passed. Store at acontrolled room temperature in a dry place.

SHELF LIFE

See the product label for the device shelf life. Do not use thedevice beyond the labeled shelf life.

MR INFORMATION





MRI-Related Heating

In non-clinical testing, the coil implant produced a maximumtemperature rise of 1.7°C during MRI performed for 15 minutes ofscanning in the 3 Tesla (3-Tesla/128-MHz, Excite, HDx, Software14X.M5, General Electric Healthcare, Milwaukee, WI) MR system.


Image Artifact InformationMR image quality may be compromised if the area of interest is inthe exact same area or relatively close to the position of the coilimplant. Therefore, optimization of MR imaging parameters tocompensate for the presence of this device may be necessary.


MATERIALS


SYMBOLS

Lot Number

Order Number

Content





80 mm2

633 mm2

179 mm2

- 5 -

Do Not Reuse

Use-by Date

Date of Manufacture



Power ON and OFF

CE Mark

Manufacturer


MR Conditional

Non-pyrogenic


WARRANTY

Terumo warrants that reasonable care has been used in thedesign and manufacture of this device. This warranty is in lieu ofand excludes all other warranties not expressly set forth herein,whether expressed or implied by operation of law or otherwise,including, but not limited to, any implied warranties ofmerchantability or fitness for particular purpose. Handling,storage, cleaning, and sterilization of the device as well as factorsrelating to the patient, diagnosis, treatment, surgical procedure,and other matters beyond Terumo’s control directly affect the device and the results obtained from its use. Terumo’s obligation under this warranty is limited to the repair or replacement of thisdevice through its expiration date. Terumo shall not be liable forany incidental or consequential loss, damage or expense directlyor indirectly arising from the use of this device. Terumo neitherassumes, nor authorizes any other person to assume for it, anyother or additional liability or responsibility in connection with thisdevice. Terumo assumes no liability with respect to devicesreused, reprocessed or resterilized and makes no warranties,expressed or implied, including, but not limited to, merchantabilityor fitness for intended use, with respect to such device.

Prices, specifications, and model availability are subject tochange without notice.



MicroVention® is a registered trademark of MicroVention, Inc.

Manufacturer:

MicroVention, Inc.1311 Valencia AvenueTustin, CA 92780 USA Tel: (714) 247-8000www.microvention.com

Distributed by: Terumo Medical Corporation2101 Cottontail Lane Somerset, NJ 08873 Tel: (800) 862-4143


MicroVention Europe30 bis, rue du Vieil Abreuvoir78100 Saint-Germain-en-LayeFranceTel: +33 (0)1 39 21 77 46Fax: +33 (0)1 39 21 16 01

0297

PD110089 Rev. B Revised 2012-11

PD110323 Rev. A 1 MicroVention, Inc.


Detachable

PD03069 Rev. A

Revised 2009-060297

Manufacturer:MicroVention, Inc.

1311 Valencia Avenue

Tustin, CA 92780 USA

Tel: (714) 247-8000

www.microvention.com

Distributed by:Terumo Medical Corporation

2101 Cottontail Lane

Somerset, NJ 08873

Tel: (800) 862-4143

Authorized European Representative:Terumo Europe N.V.

Researchpark Zone 2 Haasrode

Interleuvenlaan 40

B-3001 Leuven

Belgium

Tel: +32 16 38 12 11

®

®


EnglishAzur® CX Peripheral Coil System

(Detachable)Instructions for Use

DEVICE DESCRIPTIONThe Detachable Azur CX Peripheral Coil System (Azur system) consists of a coil implant attached to a delivery system. The coils are platinum coils with an inner layer of hydrophilic polymer. The delivery pusher is powered by an Azur Detachment Controller to selectively detach the coils. The Azur Detachment Controller is provided separately.

The Azur system is available in a broad range of coil diameters and lengths. The coil must be delivered only through a wire-reinforced microcatheter with the inner diameter specified.

Table 1

Coil TypeMicrocatheter I.D. Reposition

Timeinches mm

Azur Detachable 18 0.021 - 0.027 0.53 - 0.69 30 minutes

INDICATIONS FOR USEThe Azur system is intended to reduce or block the rate of blood flow in vessels of the peripheral vasculature. It is intended for use in the interventional radiologic management of arteriovenous malformations, arteriovenous fistulae, aneurysms, and other lesions of the peripheral vasculature.

This device should only be used by physicians who have undergone training in the use of the Azur system for embolization procedures as prescribed by a representative from Terumo or a Terumo-authorized distributor.

CONTRAINDICATIONSUse of the Azur system is contraindicated in any of the following circumstances:• Whensuperselectivecoilplacementisnotpossible.• Whenendarteriesleaddirectlytonerves.• Whenarteriessupplyingthelesiontobetreatedarenotlargeenoughtoaccept

emboli.• WhentheA-Vshuntislargerthanthecoil.• Inthepresenceofsevereatheromatousdisease.• Inthepresenceofvasospasm(orlikelyonsetofvasospasm).

POTENTIAL COMPLICATIONSPotential complications include, but are not limited to: hematoma at the site of entry, vessel/aneurysm perforation, unintended parent artery occlusion, incomplete filling, vascular thrombosis, hemorrhage, ischemia, vasospasm, edema, coil migration or misplacement, premature or difficult coil detachment, clot formation, revascularization, post-embolization syndrome, and neurological deficits including stroke and possibly death.

The physician should be aware of these complications and instruct patients when indicated. Appropriate patient management should be considered.

REQUIRED ADDITIONAL ITEMS• AzurDetachmentController• Wire-reinforcedmicrocatheterwithdistaltipROmarker,appropriatelysized• Guidecathetercompatiblewithmicrocatheter• Steerableguidewirescompatiblewithmicrocatheter• 2rotatinghemostaticYvalves(RHV)• 1three-waystopcock• Pressurizedsterilesalinedrip• 1one-waystopcock• Stopwatchortimer



• TheAzursystemissuppliedsterileandnon-pyrogenicunlesspackageisopenedor damaged.

• Thisdeviceisintendedforsingleuseonly.Donotreuse,reprocessorresterilize.Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness, or death. Reuse, reprocessing, or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.

• Angiographyisrequiredforpre-embolizationevaluation,operativecontrol,andpost-embolization follow up.

• Donotadvancethedeliverypusherwithexcessiveforce.Determinethecauseofany unusual resistance, remove the Azur system, and check for damage.

• AdvanceandretracttheAzursystemslowlyandsmoothly.RemovetheentireAzursystemifexcessivefrictionisnoted.IfexcessivefrictionisnotedwithasecondAzur system, check the microcatheter for damage or kinking.

• Thecoilmustbeproperlypositionedinthevesseloraneurysmwithinthespecifiedreposition time from the time the device is first introduced into the microcatheter. If the coil cannot be positioned and detached within this time, simultaneously remove the device and the microcatheter. Positioning the device in a low-flow environment may increase the reposition time.

• Ifrepositioningisnecessary,takespecialcaretoretractthecoilunderfluoroscopyin a one-to-one motion with the delivery pusher. If the coil does not move in a one-to-one motion with the delivery pusher, or if repositioning is difficult, the coil may have become stretched and could possibly break. Gently remove and discard the entire device.

• Duetothedelicatenatureofthecoils,thetortuousvascularpathwaysthatleadto certain lesions, and the varying morphologies of the vasculature, a coil may occasionally stretch while being maneuvered. Stretching is a precursor to potential coil breakage and migration.

• Ifacoilmustberetrievedfromthevasculatureafterdetachment,donotattempttowithdraw the coil with a retrieval device, such as a snare, into the delivery catheter. This could damage the coil and result in device separation. Remove the coil, microcatheter, and any retrieval device from the vasculature simultaneously.

• Deliveryofmultiplecoilsisusuallyrequiredtoachievethedesiredocclusionof some vasculatures or lesions. The desired procedural endpoint is usually angiographic occlusion. The filling properties of the coils facilitate angiographic occlusion.

• Tortuosityorcomplexvesselanatomymayaffectaccurateplacementofthecoil.

• Thelong-termeffectofthisproductonextravasculartissueshasnotbeenestablished so care should be taken to retain this device in the intravascular space.

• AlwaysensurethatatleasttwoAzurDetachmentControllersareavailablebeforestarting an Azur system procedure.

• ThecoilcannotbedetachedwithanypowersourceotherthananAzurDetachment Controller.

• DoNOT place the delivery pusher on a bare metallic surface.

• Alwayshandlethedeliverypusherwithsurgicalgloves.

• DoNOTuseinconjunctionwithradiofrequency(RF)devices.

PREPARATION FOR USE1. Refer to Figure 1 for the set-up diagram.

2. Attach a rotating hemostatic valve (RHV) to the hub of the guiding catheter. Attach a 3-way stopcock to the side arm of the RHV and then connect a line for continuous infusion of flush solution.

3. Attach a second RHV to the hub of the microcatheter. Attach a 1-way stopcock to the sidearm of the second RHV and connect the flush solution line to the stopcock.

4. Openthestopcockandflushthemicrocatheterwithsterileflushsolutionandthen close the stopcock. To minimize the risk of thromboembolic complications, it is critical that a continuous infusion of appropriate sterile flush solution be maintained into the guide catheter, the femoral sheath and the microcatheter.

CATHETERIZATION OF THE LESION5. Using standard interventional procedures, access the vessel with a guide

catheter. The guide catheter should have an inner diameter (ID) large enough to allow for contrast injection while the microcatheter is in place. This will allow for fluoroscopic road mapping during the procedure.

6. Select a microcatheter with the appropriate inner diameter. After the microcatheter has been positioned inside the lesion, remove the guidewire.

COIL SIZE SELECTION7. Perform fluoroscopic road mapping.

8. Measure and estimate the size of the lesion to be treated.

9. For aneurysm occlusion, the diameter of the first and second coils should never be less than the width of the aneurysm neck or the propensity for the coils to migrate may be increased.

10. For vessel occlusion, select a coil size that is slightly larger than the vessel diameter.

11. Correctcoilselectionincreaseseffectivenessandpatientsafety.Occlusiveefficiency is, in part, a function of compaction and overall coil mass. In order tochoosetheoptimumcoilforanygivenlesion,examinethepre-treatmentangiograms. The appropriate coil size should be chosen based upon angiographic assessment of the diameter of the target or parent vessel, aneurysm dome and aneurysm neck.

MicroVention, Inc. 2 PD110323 Rev. A




Indicator Light

Azur delivery pusher

Detachment Button

Funnel

Insertion Direction

12. Remove the Azur Detachment Controller from its protective packaging. Pull the white pull-tab from the side of the detachment controller. Discard the pull-tab and place the detachment controller in the sterile field. The Azur Detachment Controller is packaged separately as a sterile device. Do not use any power source other than the Azur Detachment Controller to detach the coil. The Azur Detachment Controller is intended to be used on one patient. Do not attempt to re-sterilize or otherwise re-use the Azur Detachment Controller.

13. Priortousingthedevice,removetheproximalendofthedeliverypusherfrom the packaging hoop. Use care to avoid contaminating this end of the delivery pusher with foreign substances such as blood or contrast. Firmly insert theproximalendofthedeliverypusherintothefunnelsectionoftheAzurDetachment Controller. See Figure 2. Do not push the detachment button at this time.

14. Waitthreesecondsandobservetheindicatorlightonthedetachmentcontroller.

• Ifthegreenlightdoesnotappearorifaredlightappears,replacethedevice.

• Ifthelightturnsgreen,thenturnsoffatanytimeduringthethree-secondobservation, replace the device.

• Ifthegreenlightremainssolidgreenfortheentirethree-secondobservation,continue using the device.

15. Holdthedevicejustdistaltotheshrink-lockandpulltheshrink-lockproximallytoexposethetabonintroducersheath.SeeFigure3.

Figure 3 – Pull Shrink Lock Proximally

Tab on introducer sheath Pull shrink-lock proximally

16. Slowly advance the coil out of the introducer sheath and inspect the coil for any irregularities or damage. If any damage to the coil or delivery pusher is observed, DO NOT use the device.

17. Withthedistalendoftheintroducersheathpointeddownward,gentlyretracttheimplant back completely into the introducer sheath about 1 to 2 cm.

INTRODUCTION AND DEPLOYMENT OF THE AZUR SYSTEM18. OpentheRHVonthemicrocatheterjustenoughtoaccepttheintroducersheath

of the Azur system.

19. Insert the introducer sheath of the Azur system through the RHV. Flush the introduceruntilitiscompletelypurgedofairandsalineflushexitstheproximalend.

20. Seat the distal tip of the introducer sheath at the distal end of the microcatheter hub and close the RHV lightly around the introducer sheath to secure the RHV to the introducer. Do not over-tighten the RHV around the introducer sheath. Excessive tightening could damage the device.

Azur delivery pusher proximal end connects to detachment controller

One-way stopcockLine to flush solution 3-way stopcockLine to flush solution

Guide catheter

Blood vessel

Femoral sheath

Microcatheter Distal Tip RO marker band

Coil Implant Microcatheter

RHV

Line to flush solution

3-way stopcock

RHV


34. WhentheAzurDetachmentControllerisproperlyconnectedtothedeliverypusher, a single audible tone will sound and the light will turn green to signal that it is ready to detach the coil. If the detachment button is not pushed within 30 seconds, the solid green light will slowly flash green. Both flashing green and solid green lights indicate that the device is ready to detach. If the green light does not appear, check to ensure that the connection has been made. If the connection is correct and no green light appears, replace the Azur Detachment Controller.

35. Verify the coil position before pushing the detachment button.

36. Pushthedetachmentbutton.Whenthebuttonispushed,anaudibletonewillsound and the light will flash green.

37. At the end of the detachment cycle, three audible tones will sound and the light will flash yellow three times. This indicates that the detachment cycle is complete. If the coil does not detach during the detachment cycle, leave the Azur Detachment Controller attached to the delivery pusher and attempt another detachment cycle when the light turns green.

38. The light will turn red after the number of detachment cycles specified on theAzurDetachmentControllerlabeling.DONOTusetheAzurdetachmentcontroller if the light is red. Discard the Azur Detachment Controller and replace it with a new one when the light is red.

39. Verify detachment of the coil by first loosening the RHV valve, then pulling back slowly on the delivery system and verifying that there is no coil movement. If the implant did not detach, do not attempt to detach it more than two additional times. If it does not detach after the third attempt, remove the delivery system.

40. After detachment has been confirmed, slowly retract and remove the delivery pusher. Advancing the delivery pusher once the coil has been detached involves the risk of aneurysm or vessel rupture. Do NOT advance the delivery pusher once the coil has been detached.

41. Verify the position of the coil angiographically through the guide catheter.

42. Additional coils may be deployed into the lesion as described above. Prior to removing the microcatheter from the treatment site, place an appropriately sized guidewire completely through the microcatheter lumen to ensure that no part of the last coil remains within the microcatheter.

Thephysicianhasthediscretiontomodifythecoildeploymenttechniquetoaccommodatethecomplexityandvariationinembolizationprocedures.Anytechniquemodifications must be consistent with the previously described procedures, warnings, precautions and patient safety information.

SPECIFICATIONS FOR AZUR DETACHMENT CONTROLLER• Outputvoltage:8±1VDC• Cleaning,preventativeinspection,andmaintenance:TheAzurDetachment

Controller is a single use device, preloaded with battery power, and packaged sterile.Nocleaning,inspection,ormaintenanceisrequired.Ifthedevicedoesnotperform as described in the Detachment section of these Instructions, discard the Azur Detachment Controller and replace it with a new unit.

• TheAzurDetachmentControllerisasingleusedevice.Donotreuse,reprocessorresterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness, or death. Reuse, reprocessing, or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.

• Batteriesarepre-loadedintotheAzurDetachmentControllers.Donotattempttoremove or replace the batteries prior to use.

• Afteruse,disposeoftheAzurDetachmentControllerinamannerconsistentwithlocal regulations.

PACKAGING AND STORAGEThe Azur system is placed inside a protective, plastic dispenser hoop and packaged in a pouch and unit carton. The Azur system and dispenser hoop will remain sterile unlessthepackageisopened,damaged,ortheexpirationdatehaspassed.Storeatacontrolled room temperature in a dry place.

The Azur Detachment Controller is packaged separately in a protective pouch and carton. The Azur Detachment Controller has been sterilized; it will remain sterile unlessthepouchisopened,damaged,ortheexpirationdatehaspassed.Storeatacontrolled room temperature in a dry place.

SHELF LIFESee the product label for the device shelf life. Do not use the device beyond the labeled shelf life.

MR INFORMATION The coil implant has been determined to be MR conditional according to the

terminology specified in the American Society for Testing and Materials (ASTM) International, Designation: F2503-08.

Non-clinical testing demonstrated that the coil implant is MR conditional. A patient can be scanned safely, immediately after placement under the following conditions:

• Staticmagneticfieldof3Teslaorless

• Maximumspatialgradientfieldof720Gauss/cmorless

21. Push the coil into the lumen of the microcatheter. Use caution to avoid catching the coil on the junction between the introducer sheath and the hub of the microcatheter. Initiate timing using a stopwatch or timer at the moment the device enters the microcatheter. Detachment must occur within the specified reposition time.

22. PushtheAzursystemthroughthemicrocatheteruntiltheproximalendofthedeliverypushermeetstheproximalendoftheintroducersheath.LoosentheRHV. Retract the introducer sheath just out of the RHV. Close the RHV around the delivery pusher. Slide the introducer sheath completely off of the delivery pusher. Use care not to kink the delivery system. To prevent premature hydration of the Azur system, ensure that there is flow from the saline flush.


24. At this time, fluoroscopic guidance should be initiated. Depending on length of microcatheterused,fluoroscopyinitiationmaybedelayedtominimizeexposure.

25. Under fluoroscopic guidance, slowly advance the coil out the tip of the microcatheter. Continue to advance the coil into the lesion until optimal deployment is achieved. Reposition if necessary. If the coil size is not suitable, remove and replace with another device. If undesirable movement of the coil is observed under fluoroscopy following placement and prior to detachment, remove the coil and replace with another more appropriately sized coil. Movement of the coil may indicate that the coil could migrate once it is detached. DO NOT rotate the delivery pusher during or after delivery of the coil into the vasculature. Rotating the delivery pusher may result in a stretched coil or premature detachment of the coil from the delivery pusher, which could result in coil migration. Angiographic assessment should also be performed prior to detachment to ensure that the coil mass is not protruding into undesired vasculature.

26. Complete the deployment and any repositioning so that the coil will be detached within the reposition time specified in Table 1. After the specified time, the swelling of the hydrophilic polymer may prevent passage through the microcatheter and damage the coil. If the coil cannot be properly positioned and detached within the specified time, simultaneously remove the device and the microcatheter.

27. AdvancethecoilintothedesiredsiteuntiltheradiopaquemarkeronthedeliverypusherisalignedorslightlydistalofmicrocatheterdistaltipROmarker,positioning the detachment zone just outside the microcatheter tip. See Figure 4.

28. Tighten the RHV to prevent movement of the coil.

29. Verify repeatedly that the distal shaft of the delivery pusher is not under stress beforecoildetachment.Axialcompressionortensioncouldcausethetipofthemicrocatheter to move during coil delivery. Catheter tip movement could cause the aneurysm or vessel to perforate.


Coil Implant

Proximal end of coil is aligned with microcatheter RO tip

Microcatheter Distal Tip RO MarkerDistal end of delivery pusher

Microcatheter

To minimize the potential risk of aneurysm or vessel perforation DO NOT advance the distal end of the delivery system past the distal tip of the microcatheter.

DETACHMENT OF THE COIL30. The Azur Detachment Controller is pre-loaded with battery power and will

activate when a delivery pusher is properly connected. It is in a “power off” mode when no delivery pusher is attached. It is not necessary to push the button on the side of the Azur Detachment Controller to activate it.

31. Verify that the RHV is firmly locked around the delivery pusher before attaching the Azur Detachment Controller to ensure that the coil does not move during the connection process.

32. Although the delivery pusher’s gold connectors are designed to be compatible with blood and contrast, every effort should be made to keep the connectors free of these items. If there appears to be blood or contrast on the connectors, wipe the connectors with sterile water or saline solution before connecting to the Azur Detachment Controller.

33. ConnecttheproximalendofthedeliverypushertotheAzurDetachmentControllerbyfirmlyinsertingtheproximalendofthedeliverypusherintothefunnel section of the Azur Detachment Controller. See Figure 2.