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Ovation® Platform: THE WORKHORSE SYSTEM

Gerard Mertikian

Interventional Radiology

Hietzing Hospital

Vienna-Austria ©2016 TriVascular, Inc. Caution: Federal (USA) law restricts this device to sale

by or on the order of a physician LINC 2016 Leipzig , 27.01.2016

Disclosure

Speaker name: Gerard Mertikian, MD

.................................................................................

I have the following potential conflicts of interest to report:

Consulting – TriVascular Medical Educator

Employment in industry

Stockholder of a healthcare company

Owner of a healthcare company

Other(s)

I do not have any potential conflict of interest

X

1Morrison T, Fillinger M, Meyer C, et al. Gender disparities in endovascular treatment

options for infrarenal abdominal aortic aneurysms.

http://www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UC

M359044.pdf. Published June 25, 2013.

• Nearly 35% of men and 60% of

women remain ineligible for

EVAR

• Limitations based on narrow

access vessels

• Inadequate neck length was a

main driver of ineligibility

• Treatment options limited to

surgical repair, fenestrated /

branched endografts, off-label

EVAR, or watchful waiting

Limitations of Conventional EVAR1

= Unmet Clinical Needs

©2016 TriVascular, Inc. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician

Inflatable rings for optimal

seal

Suprarenal nitinol stent with

Anchors for fixation

15F OD Aortic Body

Filled with a low-viscosity,

Radiopaque, fill polymer

12-15F OD conformable

Iliac limbs

Ovation Abdominal Stent Graft Tri-modular Design


TriVascular Ovation Primary Seal


Conventional

sealing in

collar

Water tight

seal in ring

Ovation neck length indication > 7mm

Ovation sealing concept


Conventional stentgrafts use wire and fabric to create discontinuous points of apposition

Ovation’s sealing ring provides continuous apposition, even in irregular and /or tapered anatomy

conventional

stentgraft

Ovation Prime

sealing rings

Note: FEA simulations indicate high stress points in pink and red coloring

©2016 TriVascular, Inc. Caution: Federal (USA) law restricts this device to sale by or on the order of a

physician

Self-Expanding Stent Grafts Performance in Reverse-Taper Neck

Illustration of Potential Proximal Neck Expansion Over Time

Neck dilatation may result

in Type I endoleak

and / or migration

Neck dilatation Proximal stent oversized

at renals

Ovation Platform Protects the Aortic Neck

*Based on all known peer-reviewed published clinical data with clearly outlined methodology to measure neck dilation in patients with

self-expanding AAA stent grafts; measurement methodology in cited studies is comparable to measurement methodology in Ovation

Pivotal Trial3,4.

1Monahan JVS 2010: 52: 303-7 N=46. Devices: Cook Zenith 2Rodway Eur J Endovasc Surg 2008; 35: 685-93 EVAR: N=67, Open: N=56. Data available for up to 2 years. 3Core Lab evaluation, Ovation Global Pivotal Trial. N=94. Data as of July 31, 2015 4Neck dilation in proximal neck defined as growth > 3mm at 10mm below renals, 13mm below renals, and 15mm below renals

Ovation Global Pivotal study demonstrates encouraging results with stable neck diameter

and durable seal through 4 years due to the unique sealing ring technology which creates

no chronic outward force and insulates the neck from blood pressure.


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Ovation System3,4

Self-Expanding Stents1

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Ovation iX™ Abdominal Stent Graft System


Less Invasive

• Ovation iX stands for integrated exchange

• Delivery systems now equipped with an integral, leave behind sheath

- Minimize vessel trauma

- Reduce procedural steps and ancillary devices

Ovation iX Aortic Body Confidence. Delivered.

• Integrated cross-over lumen facilitates reliable contralateral gate

access

• Optional alternative to retrograde cannulation ensures procedural

predictability even in challenging anatomies

Cross-over Lumen Cross-over Lumen Port

(0.018” wire)


Use of Aortic Body Crossover Lumen • Advance .018”guidewire thru crossover lumen

observing under fluoroscopy as it exits the contralateral leg of the iX aortic body • Use an introducer tool with the 0.18” wire

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Guidewire

Lumen 0.035” wire

0.018” wire

Blue cap

Crossover

Lumen Port

Note the wire will exit the lumen between the 2nd and

3rd ring on the contralateral leg of the aortic body


Ovation iX Iliac Stent Graft


Expanded Options

– Broader size matrix enables treatment of a wider range of AAA anatomies

- Flared limbs up to 28mm diameter

- Limb lengths up to 160mm

– Profile reduced by 1 Fr for all sizes to improve access

Patency by Design

• Designed to be kink resistant even in the most tortuous iliac anatomy

• 1.2% limb occlusion rate at one year

Ovation iX Abdominal Stent Graft System


Labeled Diameter

(MM)

Labeled Lengths (MM) Native Iliac Vessel ID Range

(MM)

Inner Diameter

Outer Diameter

10 80 100 120 140 160 8-9 10 F 12 F

12 80 100 120 140 160 10-11 10 F 12 F

14 80 100 120 140 160 12-13 10 F 12 F

16 80 100 120 140 160 14-15 11 F 13 F

18 80 100 120 140 160 16-17 11 F 13 F

22 80 100 120 140 160 18-20 12 F 14 F

28 80 100 120 140 160 21-25 13 F 15 F

Stent Graft Diameter

(MM)

Aortic ID (MM)

Max Aortic Vessel Diameter at Anchors

(MM)

Inner Diameter

Outer Diameter

20 16 – 17 24 12 F 14 F

23 18 – 20 26 12 F 14 F

26 21 – 23 29 12 F 14 F

29 24 – 26 32 12 F 14 F

34 27 – 30 35 13 F 15 F

Aortic Body Sizing

Iliac Stent Graft Sizing

OVATION® Post-Market Registry

• Multicenter, prospective, post-market study • 501 patients enrolled @ 30 sites across Europe • Enrolled May 2011 – December 2013 • Safety and Performance Endpoints assessed by Investigator

at 1-month, 6-month, and annually to 5 years

• Study Completion: 2019 • Primary Endpoints

– Technical success – Freedom from Type I and III endoleaks, aneurysm rupture,

expansion, conversion, occlusion, and migration

• CEC adjudication of device related adverse events

14 ©2016 TriVascular, Inc. Caution: Federal (USA) law restricts this

device to sale by or on the order of a physician

Anatomical Characteristics

Aortic Neck Length (N=460*)

Minimum Access Vessel Diameter (N=396*)

* Investigator reported measurements.

• 21% of treated aortic necks were shorter than 15mm • 42% had moderate/severe

calcification (N=440) • 49% had moderate/severe thrombus

(N=434)

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• 41% of patients treated had minimum access vessel less than 7mm in diameter

• Smallest vessel diameter treated was 2.9mm

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OVATION Post-Market Registry 2-Year Results

16

Performance1 30 Day 1 Year 2 Years

Type I Endoleaks 0.9% (4/432) 1.6% (6/377) 0.6% (2/337)

Type III Endoleaks 0.5% (2/432) 0.3% (1/377) 0.0% (0/337)

Migration Baseline 0.7% (2/273) 0.4% (1/236)

AAA Diameter Stable / Decreasing Baseline 99.6% (237/238) 93.1% (190/204)

Results as of January 8, 2016 based on investigator reported data. Data collected based on appropriate / available imaging modality.

1-Ns represent the number of completed follow-up visits for 1m, 1yr, and 2yr.

Technical Success All

N=501

Successful, delivery and deployment of one aortic body and two iliac limbs

99.8%

Safety 0 to 30 Days

N=501 31 to 365 Days

N=499 366 to 730 Days

N=469

Rupture 0.2% 0% 0%

Conversion to Open Repair 0% 0.2% 0.4%


OVATION Post Market Registry Summary

• Over 8,500 patients worldwide have been treated with Ovation Abdominal Stent Graft platform, with over 1,000 subjects in a tightly controlled study or registry

• Patient demographics, anatomical characteristics, and procedural characteristics indicate a challenging patient cohort.

• These data provide compelling evidence that the Ovation system can expand EVAR access to more patients and improve EVAR outcomes for all patients

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Data Hietzing Hospital

• 39 patients (35 male /4 female)

• ø 71,3 yrs. (58,4-87)

• 6 Ovation/ 31 Ovation Prime/ 2 Ovation iX

• 37 AAA/ 1 PAU / 1 CIA-Aneurysm



• Aneuyrsm diam. Ø 58,4 mm (35-79)

• 28/39 > 90° Thrombus

• 31/39 Ca+2

• Neck diam. at 13mm Ø 23,3 mm (17-30)



• Hypertension 74,36% (29/39)

• Hyperlipidemia 76,9% (30/39)

• CHD 56,4% (22/39)

• Nicotine 56,4% (22/39)

• PAD 35,9% (14/39)

• Diabetes mellitus 20,5% (8/39)

• COPD 28,2% (11/39)

• CAD 30,8% (12/39)

• CRF 23% (9/39)


physician


• 75/78 PEVAR (Prostar XL/Proglide)

• 28/39 G.A./epidural (71,8%)

• 11/39 L.A. (28,2%)

• 39/39 technical success(100%)

• EL 14/39 (35,9%)

• 11/39 EL IIa/b (78,6%/28,2%)

• 4/11 EL II-Resolution (36,4%)

• 2/19 EL Ia (14,3%/5%)

• 1/39 EL III (7,1%/2,6%)

• 30/36 aneurysm sack stable or shrinking (83,3%)

• 2/36 sack enlargement

• 3/39 lost to follow up

• 5/39 deceased (unrelated causes)


physician

Adverse Events

• 5/75 surgical repair of puncture site

• 1/39 toe gangrene

• 1/39 blue toe syndrome (resolved)

• 1/39 kidney infarction (GFR>60)

• 2/39 limb occlusion (1 lysis + stent/ 1 surg. Thrombectomy + stent)

• 1/39 occlusion of comm. fem. at access site

• 1/39 sealing ring broke upon premature inflation

©2016 TriVascular, Inc. Caution: Federal (USA) law restricts this


Secondary interventions

• Stent sup. mesenteric artery (weight loss)

• Renal stent

• Broken sealing ring – Palmaz Stent

• EL Ia – embolization (Coils and Onyx)

• EL Ia – Palmaz Stent

• EL IIb – embolization (Glue and Onyx)

• EL III – overstenting

©2016 TriVascular, Inc. Caution: Federal (USA) law restricts this


Hostile necks

Page 1 of 2

Report Details

Creation Date: 1/21/2016 Physician: Sadrija, Avni, Dr., =,,,, =

Created By: Hospital:

Received Date: City:

Reviewed Date: Country:

Pat ient Informat ion

Name: Eder, Johann

Sex: Male

Year Of Birth (Age): 1931 (83)

Study Description: Vascular^ _Aorten_Angio (Adult)

Study Date: 3/31/2014 2:35 PM

Comments:

Vessel View - Right Iliac

Diameters

ID Distance Value Label

1 6.0 mm 25.6 mm Diameter

25.1 mm Diameter


24.7 mm Diameter


24.3 mm Diameter


25.0 mm Diameter


25.8 mm Diameter


49.9 mm Diameter

Page 1 of 2

Report Details

Creation Date: 1/21/2016 Physician: Wulz, Dr. Kirsten,,, = ,,,, =





Name: Hanel, Werner

Sex: Male


Study Description: Vascular^ _BAA_BT (Adult)

Study Date: 4/8/2014 4:06 PM

Comments:


Diameters



19.0 mm Diameter



22.4 mm Diameter


58.5 mm Diameter


Hostile necks

Page 1 of 2

Report Details

Creation Date: 1/21/2016 Physician: GORLIZER, Michael





Name: BERLAKOVICH, Peter

Sex: Male


Study Description: Vascular^ _Aorta (Adult)

Study Date: 8/11/2015 1:24 PM

Comments:


Diameters



30.2 mm Diameter


54.7 mm Diameter


54.4 mm Diameter


11.5 mm Diameter


Type Ia Failed BES


Type I a


7/12 Follow-up CT


of 1

Report Details

Creation Date: 1/16/2016 Physician:




Patient Information

Name: MUeLLER Josef, Herr

Sex: Male


Study Description: AORTA

Study Date: 11/27/2013 8:38 AM

Comments:

Screenshots

Viewport capture

Page 1 of 2

Report Details

Creation Date: 1/16/2016 Physician:





Name: MUeLLER Josef, Herr

Sex: Male


Study Description:

Study Date: 11/27/2013 8:38 AM

Comments:


Diameters




25.5 mm Diameter


27.2 mm Diameter


26.5 mm Diameter



Left

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,6

Type III EL


Type III EL


Ovation iX


Conclusion

Ovation Platform: • renders EVAR possible in difficult anatomy (tortuous,

small calibre access vessels) • expands the indications for EVAR in hostile necks, while

staying within IFU • is ideally suited for PEVAR • enables EVAR in L.A. • low profile platform, without compromising material

thickness • shows good clinical results • and is a reliable workorse!


INDICATIONS FOR USE: The TriVascular Ovation platform (including Ovation, Ovation Prime and/or Ovation iX Abdominal Stent Graft Systems) is indicated for treatment of patients with abdominal aortic aneurysms having the vascular morphology suitable for endovascular repair, including: adequate iliac/femoral access compatible with vascular access techniques (femoral cutdown or percutaneous), devices, and/or accessories; proximal aortic landing zone: with an inner wall diameter of no less than 16 mm and no greater than 30 mm at 13 mm below the inferior renal artery, and with an aortic angle of ≤ 60 degrees if proximal neck is ≥ 10 mm and ≤ 45 degrees if proximal neck is < 10 mm; distal iliac landing zone: with a length of at least 10 mm, and with an inner wall diameter of no less than 8 mm and no greater than 25 mm (no greater than 20 mm for Ovation/Ovation Prime).

CONTRAINDICATIONS: The systems are contraindicated for use in patients who have a condition that threatens to infect the graft and in patients with known sensitivities or allergies to the device materials (including polytetrafluoroethylene [PTFE], polyethylene glycol [PEG]-based polymers, fluorinated ethylene propylene [FEP] or nitinol). Also consider the information in Section 4 Warnings and Precautions of the systems’ Instructions for Use.

Refer to Instructions for Use at TriVascular.com for more information concerning Indications, Contraindications, Warnings and Precautions, and Adverse Events.

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

NOTE: Not all product components are available in every country. Please consult with your TriVascular representative to confirm product availability.

CE marked. Please refer to current product Instructions for Use.


Ovation® Platform: THE WORKHORSE SYSTEM

Gerard Mertikian

Interventional Radiology

Hietzing Hospital

Vienna-Austria ©2016 TriVascular, Inc. Caution: Federal (USA) law restricts this device to sale

by or on the order of a physician LINC 2016 Leipzig , 27.01.2016

ovation® platform: the workhorse system · ovation® platform: the workhorse system gerard...

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