4 Year Results from the Ovation® Global Pivotal Trial

Venkatesh Ramaiah, MD, FACS

Medical Director, Arizona Heart Hospital

Director, Peripheral Vascular and Endovascular Research, Arizona Heart Institute

Disclosure

Speaker name: Venkatesh Ramaiah, MD, FACS

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

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) – National Co-Principal Investigator LIFE Study

I do not have any potential conflict of interest

X

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/UCM359044.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

Persistent EVAR Challenges Characteristics of Hostile Access Anatomy

• Narrow (<6mm)

• Occluded

• Tortuous

• Calcified

• Aneurysmal

Narrow Access Vessels

Access Vessel Tortuosity

40% Patients < 6mm* M2S Database – 43,000 CT Scans

3.2 mm 5.3 mm

55% Female Patients <6mm** (CHAP) Collaborative effort – 1,063 CT Scans

* Derived from M2S Measurement Database of 43,000 AAA CT Scans

** New England Society for Vascular Surgery, Matthew P. Sweet, MD et all

The influence of gender and aortic aneurysm size on eligibility for endovascular abdominal aortic aneurysm repair Clinician-FDA

Collaborative effort, Characterization of Human Aortic Anatomy Project (CHAP), 1063 CT Scans

Persistent EVAR Challenges Characteristics of Hostile Neck Anatomy

• Short Aortic Necks (<15mm)

• Reverse Tapered Necks

• Calcium

• Thrombus

• Severe Angulation

• Large Diameter 48% Patients < 15mm Necks*

M2S Database – 43,000 CT Scans

63% Women < 15mm Necks** (CHAP) Collaborative effort – 1,063 CT Scans

Calcium/Thrombus lined Necks

Reverse Tapered Necks At Inferior

Renal Artery

At IR + 5

At IR + 13

* Derived from M2S Measurement Database of 43,000 AAA CT Scans

** New England Society for Vascular Surgery, Matthew P. Sweet, MD et all

The influence of gender and aortic aneurysm size on eligibility for endovascular abdominal aortic aneurysm repair

Clinician-FDA Collaborative effort, Characterization of Human Aortic Anatomy Project (CHAP), 1063 CT Scans

FDA Approved EVAR Devices

Excluder Endologix Endurant Ovation Lombard Zenith

Additional CE Mark EVAR Devices

Cordis Incraft® Bolton Treovance® Endologix Nellix®

Ovation Global Pivotal Trial A pivotal clinical evaluation of the safety and effectiveness of the TriVascular Ovation Abdominal Stent Graft System

Primary Endpoint:

• MAE within 30 days of the procedure, as determined by Clinical Events Committee

Primary Effectiveness Endpoint:

• Treatment success defined as:

– Successful Delivery and Deployment

– Freedom from Rupture and Conversion to Open Surgical Repair

– Freedom from Type I and III Endoleaks, Migration, and Enlargement as determined by Core Lab

Follow-up: 1 month, 6 month and annual to 5 years

Investigator Site

Botti, Charles Riverside Methodist Hospital

Cheema, Mohiuddin Hartford Hospital

Clair, Daniel Cleveland Clinic

Eidt, John Central Arkansas VA

Eskandari, Mark Northwestern Memorial

Glickman, Mark Sentara Medical Group

Gray, Bruce Greenville Hospital

Haser, Paul UMDNJ

Hassoun, Heitham Methodist Hospital

Henretta, John Mission Hospital

Hodgson, Kim Southern Illinois University

Jain, Ash Washington Hospital

Jicha, Douglas Santa Rosa Memorial

Jones, Paul Mercy Medical Center

Jordan, William UAB

Kasirajan, Karthik Emory University

Krajcer, Zvonimir St. Luke’s Hospital

Laird, John UC Davis

Maini, Brijeshwar Moffitt Heart and Vascular

Makaroun, Michel UPMC

Maldonado, Thomas NYU Hospital

Mehta, Manish Albany Medical Center

Mishkel, Gregory Prairie Heart

Moore, Wesley UCLA

Motew, Stephen Forsyth Medical Center

Murkherjee, Dipankar Inova Fairfax Hospital

Rizvi, Adnan Minneapolis Heart Institute

Sternberg, Charles Ochsner Health System

Investigator Site

Brunkwall, Jan Uni. Klinik Koln

Krankenberg, Hans Medizinisches Versorgungszentrum, HH

Mathias, Klaus Klinikum Dortmund

Nolte, Thomas Herz und Gefaßzentrum, Bad Bevensen

Scheinert, Dierk Park Krankenhaus, Leipzig

Sievert, Horst CVC, Frankfurt

Torsello, Giovanni St. Franziskus-Hospital, Münster

Investigator Site

Valdes, Francisco Catholic University

Ovation Global Pivotal Trial

161 patients enrolled in Chile, Germany and USA

• First Global IDE Trial • Broadest Indication Statement • Included First-In-Man at all sites

Subject Medical History

ASA Grade

- I 5.6% (9/161)

- II 28.0% (45/161)

- III 59.6% (96/161)

- IV 6.8% (11/161)

Coronary artery disease 44.7% (72/161)

Hypertension 84.5% (136/161)

Hyperlipidemia 70.2% (113/161)

Peripheral vascular disease 23.6% (38/161)

Smoking 70.2% (113/161)

COPD 27.3% (44/161)

Ovation Global Pivotal Trial

Subject Demographics

Age (Yrs) Mean ± std 73 ± 8

Gender Male % (n/N) 87.6% (141/161)

Baseline Aortoiliac Characteristics

Mean ± SD Min, Max

Aortic diameter 13mm below renal artery (mm)1

22.7 ± 3.1 16.6, 32.3

Juxtarenal angle (degrees)1 19.1 ± 13.5 0.0, 60.0

Proximal neck length (mm)2 22.9 ± 12.5 1.0, 50.0

Aortic aneurysm diameter (mm)2 53.6 ± 9.0 37.8, 90.0

Aortic bifurcation diameter (mm)2 20.3 ± 6.9 11.5, 53.5

Left iliac minimum access diameter (mm)2 7.0 ± 1.6 3.2, 11.5

Right iliac minimum access diameter (mm)2 7.0 ± 1.6 3.5, 11.4

Ovation Global Pivotal Trial

1Data provided by site imaging 2Data provided by imaging core lab

~40% (66/161) of Ovation Trial

patients treated had access vessels

<6mm, aortic neck length <10mm, or

both. Minimum

Access Vessel <6mm;

25%

Both Criteria;

8%

Neck Length; 8%

Neither Criteria;

59%

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

Ovation Global Pivotal Trial

Safety2 0 to 30 Days

N=161

31 to 365 Days

N=159

366 to 730 Days

N=154

731 to 1095 Days

N=140

1096 to 1460 Days

N=124

Major Adverse Events 2.5% 3.8% -- -- --

Device Related MAE 0% 0% -- -- --

Rupture 0% 0% 0% 0% 0%

Conversion to Open Repair 0% 0% 0% 0% 0%

Effectiveness3 30 Day 1 Year 2 Years 3 Years 4 Years

Type I and III Endoleaks 0% (0/153) 0% (0/143) 0% (0/120) 0% (0/109) 0% (0/85)

Migration Baseline 0% (0/150) 0% (0/133) 0% (0/117) 0% (0/94)

Technical Success1 All N=161

Defined as successful, delivery and deployment of one aortic body and two iliac limbs

100%

Data as of July 31, 2015 1Technical Success based on investigator reports 2Major Adverse Events and Device Related Major Adverse Events based on Clinical Events Committee (CEC) adjudicated

data. Rupture and Conversion to Open Repair based on investigator reports 3Endoleaks and Migration rates based on Core Lab Data (M2S)

4 year results of the global pivotal clinical study to evaluate the safety

and effectiveness of the TriVascular Ovation Abdominal Stent Graft System.

Ovation Platform Expands EVAR

*Device Indications from Company Instructions for Use 1In Ovation pivotal trial, neck length indication of ≥ 7mm

2In healthy landing zones. Measurement is outer wall to outer wall in diseased landing zones. 3Ovation iX Iliac Stent Graft System

TriVascular Ovation System

Cook Zenith Flex

Endologix AFX

Gore Excluder C3

Lombard Aorfix

Medtronic Endurant II

Key Indications

Proximal Neck Length

Conventional neck length

requirement1

≥ 15mm ≥ 15mm ≥ 15mm ≥ 15mm ≥ 10mm

Proximal Neck Angle (Degrees)

<60 if neck length ≥ 10

mm ≤ 45 if neck length < 10

mm

≤ 60 for infrarenal neck

or ≤45 degrees for

suprarenal neck

≤ 60 ≤ 60 ≤ 90 < 60

Neck Diameter 16-30mm Inner Wall

18-32mm Outer Wall

18-32mm Not Specified

19-32mm Inner Wall

19-33mm Inner Wall2

19-32mm Inner Wall

Iliac Diameter 8-25mm3 Inner Wall

7.5-20mm Outer Wall

10-23mm Not Specified

8-25mm Inner Wall

9-19mm Inner Wall2

8-25mm Inner Wall

Device Features

Profile OD (main body)

14F-15F 21F-23F 19F 20F 22F 18F-20F

Ovation Platform Improves EVAR

Sources: Ovation data as of June 6, 2012. Data Rates from Instructions For Use (IFU) and Annual Clinical Updates 1- Based on Investigator Reported Events 2- Source: Makaroun M. One-year outcomes of the US regulatory trial of the Endurant stent graft system. J Vasc Surg. 2011;54:601–608. Includes re-interventions on Day 0.

Safety & Effectiveness Rates at 1-year

TriVascular Ovation IDE

Cook Zenith Flex IDE

Endologix PowerLink IDE

Gore Excluder Combined IDE

Lombard Aorfix IDE

Medtronic Endurant

IDE

Patients Enrolled 161 200 192 565 218 150

Major Adverse Event 0-30 / 31-365 days

2.5% / 3.8% Not Reported 6.3% / 18% 18.6% / 17.1% 24.3% / Not

Reported 4.0% / 6.5%

All-Cause Mortality 0-30 / 31-365 days

0.6% / 1.9% 0.5% / 3.0% 1.6% / 5.2% 1.0% / 7.0% 1.8% / Not Reported

0% / 4.3%

Type I Endoleak 0% 0.6% 0.8% 0.8% 0.7% 0%

Type III Endoleak 0% 0.6% 0% 0.9% 0.7% 0%

Migration 0% 2.5% 1.6% 0.7% 1.2% 0%

AAA Rupture1 0% 0% 0% 0% 0.5% 0.8%

Conversions1 0% 1% 2.1% 1.1% 1.8% 0%

Freedom from Sac Enlargement

99.3% 98.7% 97.8% 95.0% 98.8% 100%

Limb Occlusions1 1.2% 3.0% 3.1% 0.4% 3.7% 2.7%

Subjects Requiring Re-interventions1

6.2% 11.0% 9.9% 11.5% 15.6% 6.7%2

Ovation Platform Well Suited for Percutaneous Access

Open exposure

Percutaneous 43%

Access Type

Cut-down Percutaneous

Cut-Down Percutaneous

Major Adverse Event @ 30 Days 3.3% (3/92) 1.4% (1/69)

Treatment Success @ 1-year 98.9% (91/92) 100% (69/69)

Anesthesia Time (mean) 191 minutes 149 minutes

Procedure Time (mean) 118 minutes 98 minutes

Hospitalization (median) 2 days 1 day

In the Ovation pivotal study, subjects

undergoing percutaneous access achieved

similar clinical outcomes with slightly lower

time spent related to anesthesia, procedure

and hospitalization time.

Ovation Platform Protects the Aortic Neck

0,0

2,4

3,6

4,7

5,3

0,0 0,4

0,8

0,0

-0,2 0,0

0,2 0,2

-1,0

0,0

1,0

2,0

3,0

4,0

5,0

6,0

Baseline 1 Year Growth 2 Year Growth 3 Year Growth 4 Year Growth

Pro

xim

al N

eck

dia

met

er a

vera

ge

exp

ansi

on

(m

m)

Aortic Neck Dilatation Over Time*

*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 System3,4

Self-Expanding

Stents1

Open Repair2

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.

Clinical Evidence to Validate the Ovation Platform

• 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

• At 4 years, no ruptures, conversions, Type I / III endoleaks or migrations were reported, including stable aortic neck diameter

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

The TriVascular Ovation Experience at Arizona Heart

Venkatesh Ramaiah, MD, FACS

Medical Director Arizona Heart Hospital

Director

Peripheral Vascular and Endovascular Research Arizona Heart Institute

The Ovation System at Arizona Heart

• First experience Feb 8th 2013

• 223 grafts implanted to date

– 100% technical success

• Initial interest in Ovation System:

– Short, challenging necks

– Tight, calcified and tortuous access

Ovation at AZ Heart - Results • 223 grafts implanted to date:

• 100% technical success rate

• One groin complication (pseudo aneurysm) resolved with ultrasound guided injection of thrombin.

• 1 External Iliac Artery complication (minor rupture due to pre dilatation) treated by covering with Iliac Limb

• Four intra-operative Type IA endoleaks in extremely challenging cases. All endoleaks were treated & resolved at initial implantation.

– Three by placing a Palmaz stent

– One resolved by Palmaz Stent and placing coils between the proximal and distal sealing rings.

AZ Heart Case Study

• 77 year old male

• 8.5 cm symptomatic aneurysm

Significant

juxtarenal

angle of

77deg at

IR+13

Vessel dilates

between IR+13 and

IR+16. Accurate

deployment is

essential. Calcium

and thrombus noted in

seal zone.

Length to

hypogastrics

long

bilaterally

Proximal

Right

common

iliac

aneurysmal

AZ Heart Case Study

AZ Heart Case Study

6 Month Follow-up

AZ Heart Case Study

6 Month Follow-up

Ovation at AZ Heart - Results

• 223 grafts implanted to date:

• No late Type I endoleaks

• No Type III, IV endoleaks

• One limb occlusion..Secondary to CFA/Closure

• No secondary interventions

• Average length of stay – 1.3 day

• 95% percutaneous .

• We are in the process of analyzing 1 -2 year follow up data in terms of freedom from rupture,freedom from re-intervention, migration, survival and sac shrinkage

AZ Heart Experience

Initial interest in Ovation System: Enable treatment of the most challenging anatomies

• Current status: Primary option for EVAR

• Ease and accuracy of deployment

• 14F OD Facilitates closure post PEVAR – now our preferred access method

• Patient outcomes have been extremely favorable in challenging and straightforward cases alike

• Looking ahead: Customized polymer seal offers opportunity for further enhancements to aortic disease management

Thank You

4 Year Results from the Ovation® Global Pivotal Trial

Venkatesh Ramaiah, MD, FACS

Medical Director, Arizona Heart Hospital

Director, Peripheral Vascular and Endovascular Research, Arizona Heart Institute