selectra telescopic cs lead delivery system biotronik cardiac rhythm management cardiac...

SelectraTelescopic CS Lead Delivery System

BIOTRONIK

Cardiac Rhythm Management

Cardiac Resynchronization Therapy

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Coronary sinus lead delivery system

Selectra. The first choice.

Selectra Outer Catheters

A variety of advanced catheters incorporating superior and innovative features

Selectra Inner Catheters

Optimal vessel sub-selection for direct delivery of low profile coronary sinus leads

New Selectra Slitter Tool

Ergonomic design for a smooth slitting process with lead dislodgement prevention

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Telescopic system with inner catheters

Advanced and atraumatic soft tip design

New and innovative ergonomic handle

Balanced and superior shaft design

A variety of configurations

Coronary sinus lead delivery system

Selectra. The first choice.

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The ultimate handling experience

Innovative design

The innovative handle design allows for a smooth slitting process from every angle

An integrated hemostatic valve enables effortless introduction of inner catheters or coronary sinus leads

The build-in side-port enables simultaneous manipulation and contrast injection provide an extraordinary handling experience

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Lubricious and balanced like no other

Unique handling

Superior kink resistance and sensitive torque control are achieved by smooth stiffness profiles resulting in a pushable proximal shaft and flexible distal section

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The unique hydrophilic inner coating provides excellent lubricity allowing for effortless introduction of inner catheters, delivery of coronary sinus leads and system removal

Lubricious and balanced like no other

Unique handling

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Atraumaticity matters

Superior quality

Round soft tip design provides high atraumaticity during CS cannulation minimizing the risk for dissections

During lead manipulation, the high tip stability reduces the risk for prolapse

Excellent visibility during system positioning due to highly radiopaque polymeric x-ray marker

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Teamwork

Superior quality

The combination of Selectra outer catheters with inner sub-selection catheters enables direct delivery of low profile coronary sinus leads such as the new Sentus OTW

Optimized coronary sinus cannulation and in deep-seating outer catheters due to the perfect balance of stiffness and flexibility

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Superior quality

Selectra inner catheters

Slittable in-line luer with integrated hemostatic valve for smooth slitting procedures and ergonomic one-handed manipulation and contrast injection

Hydrophilic inner coating for easy insertion of CS leads and removal of delivery system without the risk for lead dislocation

50° and 90° degree tip angulations for easy vessel sub-selection

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A variety of configurations

Eight curve shapes adapt to different patient coronary sinus anatomies

Available in 45 cm and 55 cm lengths

Unique handling

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Selectra “Straight”

For CS approach from above with EP catheter

Support

None

Shape similar to

BSX Acuity BA CS-ST

MDT Attain Command Straight

SJM CPS Direct SL Straight

Reach

None

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Selectra “BIO2”

For CS approach from above

Support

Medium, from vena cava superior

Shape similar to

SJM CPS Direct SL MP

Reach

Less

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Selectra “Multipurpose EP”

For CS approach from above

Support

Medium, from vena cava superior

Shape similar to

BSX Acuity BA CS-MP

MDT Attain Command MB2

SJM CPS Direct SL 115°

Reach

Less

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Selectra “Multipurpose Hook”

For CS approach from below

Support

Medium, from VCS right atrial wall

Shape similar to

BSX Acuity BA CS-H

MDT Attain Command MP

Reach

Medium

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Selectra “Right”

For CS approach during right-sided implants

Support

Medium, from VCS

Shape similar to

BSX Acuity BA CS-EH ST R

MDT Attain Command Right

SJM CPS Direct SL Right

Reach

Medium

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Selectra “Amplatz 6.0”

For CS approach when severe left heart dilatation is present

Support

Medium, from VCS

Shape similar to

BSX Acuity BA CS_A6

MDT Attain Command Amplatz

Reach

Medium

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Selectra “Hook”

For CS approach from above

Support

Medium, from VCS

Shape similar to

SJM CPS Direct SL 135°

Reach

Medium

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Selectra “Extended Hook”

For CS approach from below

Support

More, from VCS and right atrial wall

Shape similar to

BSX Acuity BA CS-EH

MDT Attain Command EH

SJM CPS Direct SL Wide

Reach

More

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New Selectra slitter tool

Integrated lead clip fixates the lead body during the slitting process

Secure and easy slitting of the handle and the entire catheter due to optimized blade

Ergonomic design allows for comfortable handling during catheter removal or continuation of the slitting process in case of slipping

Unique handling

Cardiac Rhythm Management

Cardiac Resynchronization Therapy

Handling Tips & Tricks

Selectra Hemostatic Valve Design- INTERNAL EDUCATION ONLY -

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INTERNALEDUCATION

ONLY

The valve is designed to ensure a low friction environment for optimal lead pushability and safety during sheath removal.

The valve consist of a proximal sealing ring and a distal back-pressure valve.

Selectra. The first choice.

Selectra hemostatic valve design

Back-pressure valve

Sealing ring

Valve closed Valve open

Insertion of tools open the back-pressure valve

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INTERNALEDUCATION

ONLY

Selectra hemostatic valve design update

The hemostatic valve performance was continuously improved based on observations from the PME and initial market feedback.

Process improvements lead to avoidance of valve prolapse during lead or catheter removal ensuring the integrity and functionality of the back-pressure valve.

Short-term: The TVI with dilator is offered separately and can be used to introduce 0.14” guide wires. The dilator seals onto the guide wire and reduces back-bleeding.

Medium-term: A new TVI which seals onto a 0.14” guide wire will be developed and included into the accessory kit.

Recommendation: Close the proximal end of the catheter with your thumb during aspiration through the side port.

Selectra hemostatic valve design.

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INTERNALEDUCATION

ONLY

Use case #1 - Nothing is inserted

Due to the fact that the venous blood pressure is higher than the atmospheric pressure the back-pressure valve is fully closed when nothing is inserted from proximal!

Selectra hemostatic valve design.

Higher pressure

Lower pressure

Nothing is inserted

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INTERNALEDUCATION

ONLY

Use case #2 - Dilator insertion

Observation:

If only a dilator is inserted, back-bleeding can occur through inner lumen of the dilator because of an “open” system.

Selectra hemostatic valve design.

Dilator

Back-bleeding

Only dilator inserted

Higher pressure

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INTERNALEDUCATION

ONLY

Use case #2 - Dilator insertion (cont.)

Solution:

Use dilator only in combination with the 0.35” guide wire in order to “close” the inner lumen of the dilator!

0.35” Guide Wire

Dilator

Dilator and guide wire inserted

Selectra hemostatic valve design.

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INTERNALEDUCATION

ONLY

Use case #3 – Valve prolapse

Observation:

Prolapse may occur when a dilator or lead is quickly removed from the sheath pulling the flap back through valve

Selectra hemostatic valve design.

Higher pressure

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INTERNALEDUCATION

ONLY

Use case #3 - Valve prolapse (cont.)

Solution:

Leakage will stop once a lead or catheter is advanced through the valve, pushing the flap back from the valve

Selectra hemostatic valve design.

Dilator, LV Lead or EP Catheter

Insert dilator or lead

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INTERNALEDUCATION

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Use case #3 - Valve prolapse (cont.)

Solution:

Process improvements aims to avoid the valve prolapse during lead or catheter removal ensuring the integrity and functionality of the back-pressure valve.

Please note that the improvement is being introduced seamlessly into running production. Therefore you may receive products before or after the process change depending on inventory. Care should be taken to observe a potential valve prolapse and if required, to take the action recommended on the previous slide.

Selectra hemostatic valve design.

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INTERNALEDUCATION

ONLY

Use case #4 - Lead or EP catheter insertion

The sealing ring fully seals onto a lead or EP catheter and no back-bleeding occurs!

Selectra hemostatic valve design.

LV Lead or EP Catheter

Lead is inserted

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INTERNALEDUCATION

ONLY

Use case #5 - Aspiration with syringe

Observation:

Aspiration can lead to lower pressure distally of the valve causing it to open slightly, which might cause air bubbles being aspirated.

Selectra hemostatic valve design.

Higher pressure

Lower pressure

Air bubbles might enter the catheter and will be directly aspirated into the syringe

Aspiration through side port

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INTERNALEDUCATION

ONLY

Use case #5 - Aspiration with syringe (cont.)

Solution:

Close the proximal end of the catheter with your thumb or sealing cap to avoid valve opening during aspiration!

After aspiration the valve closes again due to the pressure change and there is no risk of air embolism for the patient!

Selectra hemostatic valve design.

The back-pressure valve closes due to the higher pressure inside the system!Higher pressure

Lower pressure

Aspiration through side port

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INTERNALEDUCATION

ONLY

Use case #6 - Guide wire only insertion

Observation:

The sealing ring does not fully seal onto 0.14” and 0.35” guide wires if they are introduced alone, which might cause slight back-bleeding.

Selectra hemostatic valve design.

Guide Wire

Only guide wire inserted

Back-bleeding

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INTERNALEDUCATION

ONLY

Use case #6 - Guide wire only insertion (cont.)

Solution:

If only a 0.14” guide wire is inserted use the TVI with dilator. The TVI and dilator seals onto the guide wire and centers it avoiding excessive back-bleeding.

Selectra hemostatic valve design.

TVI Dilator

TVI

Guide Wire

Guide Wire and TVI with dilator inserted

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INTERNALEDUCATION

ONLY

Please treat this information confidentially!

If you have any further questions or comments please do not hesitate to contact

matthias.wenzel@biotronik.com

or

oliver.helm@biotronik.com