OVATION: custom neck seal that benefits you and your patients,cacvsarchives.org/archivesite/2017/pdf/... · Consulting - TriVascular Employment in industry Shareholder in a healthcare

OVATION: Custom Neck Seal that Benefits you and your Patients, Sustained by Long-term Data

The Ovation iX™ is approved to treat infrarenal abdominal aortic aneurysms and is not approved for any other intended use in any geography.

Disclosures

Speaker name: Lieven F. Maene, MD

I have the following potential conflicts of interest to report:

Consulting - TriVascular

Employment in industry

Shareholder in a healthcare company

Owner of a healthcare company

Other(s)

I do not have any potential conflict of interest

EVAR … Path to Durable Sealing


EVAR … Path to Durable Sealing


EVAR … Path to Durable SealingIFU


6

Endurant ZenithExcluder

Neck Length Non-traditional requirementRefer to neck length ≥15mm ≥10mm ≥15mm ≥15mm

Neck Angle ° ≤60 if neck length ≥10mm

≤45 if neck length <10mm≤60 ≤60 ≤ 60

≤60 for infrarenal neck

≤45 for suprarenal neck

Neck Diameter 16-30mm at 13mm IR 18-32mm 19-32mm 19-32mm 18-32mm

Iliac Diameter 8-25mm 10-23mm 8-25mm 8-25mm 7.5-20mm

Profile (OD) 14F 19F 18F 20F 21F

45%55%69% 50%% Patients within FDA IFU*

47%


14F OD ultra low profile enables

access to more patients

Staged deployment of suprarenal stent allows precise placement

Polymer-filled sealing ring creates a

custom seal and protects the aortic neck

Low permeability PTFE enables effective aneurysm exclusion and device patency

Conformable, kink resistant PTFE iliac limbs designed to reduce risk of occlusion


Ultra Low Profile Path to Durability with a Patient-Specific Seal

8

Ovation Platform Broadens Applicability, on-IFU

Endurant ZenithExcluder

Neck Length Non-traditional requirementRefer to neck length ≥15mm ≥10mm ≥15mm ≥15mm

Neck Angle ° ≤60 if neck length ≥10mm

≤45 if neck length <10mm≤60 ≤60 ≤ 60

≤60 for infrarenal neck

≤45 for suprarenal neck

Neck Diameter 16-30mm at 13mm IR 18-32mm 19-32mm 19-32mm 18-32mm

Iliac Diameter 8-25mm 10-23mm 8-25mm 8-25mm 7.5-20mm

Profile (OD) 14F 19F 18F 20F 21F

45%55%69% 50%% Patients within FDA IFU*

47%


Custom Seal Area: neck diameter ≥16 mm and ≤30

mm at 13mm below inferior renal (IR) artery / landing area

OVATION NECK REQUIREMENT

You Do Need an “Aortic Neck” to Achieve Seal

CONVENTIONAL NECK REQUIREMENT

Based on Neck segment ≥ 10mm or

≥15mm of parallel vessel wall

Parallel vessel wall along length of sealing zone

Circumferential seal occurs at midpoint of sealing ring at IR+13


Liquid polymer injected to inflate O-ring

Liquid polymer cures to a solid,

durable state

Water tight seal in the aorta

Uniform continuous wall apposition, even in irregular and/or tapered anatomy

Molds and conforms to aorta, offering a customized seal

Non-expansive circumferential wall apposition of sealing ring creates no chronic outward radial force and no aortic neck dilatation


Ovation Platform Custom Seals to the Patients Anatomy


Ovation Platform Custom Seals to the Patients Anatomy

Ovation and Challenging Distal Anatomy


1

Ovation Platform Clinical Compendium

36 Centers US, Chile, Germany

5 Year Results

30 Centers3 Year Results

FAST Track EVAR40 Centers30d Results

US 30 CentersEU 12 Centers

Enrolling

Alto IDE and PMR Enrollment starting

in 2017

161patients

501patients

250patients

285patients

375patients

Ovation Global Pivotal IDE

Ovation EU Post Market Registry

Over 10,000 patients worldwide have been treated with the Ovation Abdominal Stent Graft Platform, with over 1,500 patients in a prospective study


Objective: Demonstrate the clinical and cost benefits associated with the ultra-low profile (14F) Ovation Abdominal Stent Graft platform under the

least invasive conditions defined in the Fast-Track EVAR protocol:

Least Invasive Fast-Track (LIFE) EVAR Registry

• Percutaneous Access• No General Anesthesia• No ICU Admission• Next-day Discharge

1 MAE non-device nor procedure-related: death due to acute respiratory failure 28 days post procedureAs of August 2, 2016

LIFE Fast-Track PEVAR EVAR

0.4% (1/250) 0.5% (1/216)1 0% (0/26) 0% (0/8)

No Device- or Procedure-Related Major Adverse Events

EVARACS NSQIPGupta 2014

EVARACS NSQIPChen 2016

LIFE Registry

EVAR Cases (N) 2369 3886 250

Time Period 2011 2012-2013 2015-2016

Unplanned 30d Readmission 7.9% 8.1% 1.6%

Operation during Readmission 28% - 0%

Chen SL et al. Perioperative Risk Factors for Readmission Following EVAR. Presented at SCVS, 2016.

• Most common EVAR readmission drivers are MI, renal, respiratory and wound complications

• Median EVAR readmission cost $17,700 (if for graft occlusion) to $23,600 (if for endoleak)

• Cost drivers are due to additional surgeries, ICU services, and length of stay

Gupta PK, et al. Unplanned readmissions after vascular surgery. J Vasc Surg 2014;59:473-82.

ACS NSQIP: American College of Surgeons – National Surgical Quality Improvement Program

LIFE readmission rate is 5x less than contemporary EVAR reports

30d Hospital Readmissions


United States GermanyChile

161 patients enrolled in Chile, Germany and USA from Nov 2009 – Dec 2011

• First Global IDE Trial • Broadest Indication Statement • First-in-Man / No roll-in at All Sites

Ovation Global Pivotal Trial

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

Valdes, Francisco Catholic University

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


Anatomic Characteristics

~40% of patients in Pivotal IDE had access vessels <6mm, neck length <10mm, or both



Ovation IDE Endurant IDE Zenith IDE Excluder IDE

Patients Enrolled 161 150 200 / 100Std Risk / High Risk

565

ASA Class III/IV 60% / 7% 49% / 0% NR NR

Major Adverse Event 0-30d / 31-365d 2.5% / 3.8% 4.0% / 6.5% NR NR

Rupture (5 Yr) 0.6% 0.7% 0.3% 0.2%

Conversion (5 Yr) 0% 0% 2.0% 3.4%

Freedom from Migration >10mm (5 Yr) 100% 100% 100% 99%

Freedom from Sac Growth >5mm (5 Yr) 80% / 93% US 95% 91% 66%

Safety and EffectivenessLowest Reported MAE Rate Across IDE Trials for FDA-Approved AAA Devices

Results for EVAR commercially available devices shown per the respective US FDA Summary of Safety and Effectiveness Data (SSED) and Annual Clinical Reports.



Freedom from Mortality through 5 Years

98% Five Year Freedom from ARM

75% Five Year Freedom from ACM



Pre-Deployment Post-Deployment

Pre-Case 3 Year Follow-Up

Neck Length2 (Core lab measurement): 4mm

Ovation® Global Pivotal TrialCase Study Example

1Core Lab Data. Ovation Global Pivotal Trial. Neck dilatation in proximal neck defined as growth > 3mm 10mm below renals, 13mm below renals and 15 mm below renals2Physician measurement of at least 7mm neck length in pivotal trial Images are courtesy Manish Mehta, MD, Albany Medical Center, Albany NY

No Type 1 endoleak and stable neck diameter1



Adjunctive Procedures for Type Ia Endoleak

Adjunctive ProceduresFor intra-operative Type Ia endoleak

3.1% 3.2% 0.6%

EU PMRPivotal IDE LIFE Registry

CASE EXAMPLE▪ Palmaz stent used to address

intraoperative Type1a endoleak due to undersized graft.

▪ 3 year follow-up shows no neck dilatation. Palmaz stent and sealing ring maintain wall apposition.


Type Ia Endoleak Intervention through 5 Years

97% Five Year Freedom from Reintervention

for Type 1 Endoleak



Freedom from Reintervention through 5 years

97% for type I endoleak97% for occlusion90% for type II endoleak81% for all reintervention



3Core Lab evaluation, Ovation Global Pivotal Trial. N=94. Data as of Aug 2, 2016 4Neck dilation = growth > 3mm at 10mm, 13mm, and 15mm below renals

Aortic Neck Dilatation through 5 Years

CONVENTIONAL EVAR EVAR WITH OVATION

Core lab results show stable neck diameter through 5 years

1Monahan JVS 2010: 52: 303-7. N=46. Devices: Cook Zenith 2Rodway EJVES 2008;35:685-93 EVAR: N=67, Open N=56. Data to 2 years.



• Multicenter, prospective

• 501 patients, 30 EU sites

• Enrolled May 2011 – December 2013

• 5 year follow-up

• CEC adjudication of device-related adverse events

• Primary Endpoints • Technical success

• Freedom from Type I/III endoleak, rupture, sac expansion, conversion, occlusion, and migration

OVATION® EUROPEAN

POST MARKET REGISTRY


Baseline Characteristics

Pivotal IDE EU PMR

Age (mean) 73 ± 8 73 ± 8

Male Gender 87.6% (141/161) 86.2% (432/501)

ASA Class III/IV 66.4% (107/161) 48.7%

Coronary artery disease 44.7% (72/161) 40.9% (205/501)

Hypertension 84.5% (136/161) 69.1% (346/501)

Hyperlipidemia 70.2% (113/161) 47.9% (240/501)

Smoking 70.2% (113/161) 47.7% (239/501)

COPD 27.3% (44/161) 22.8 (114/501)

Patient demographics and comorbid risk factors indicate a typical AAA patient cohort.



Anatomical Characteristics

1/3 of patients had Severe Morphology

Data provided by site imaging. Severe morphology based on SVS/AAVS anatomic scoring. Chaikof et al. J Vasc Surg 2002;35:1061-1066 / Walker et al. J Vasc Interv Radiol 2010;21:1632-1655



Procedural Outcomes

60%

40%N=501

Technical Success (successful deployment of device) 99.8%

Anesthesia Time (mean) 150 minutes

Procedure Time (mean) 118 minutes

Fluoroscopy Time (mean) 22.2 minutes

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

In the Ovation study, subjects undergoing percutaneous access achieved similar clinical outcomes with slightly lower time spent related to anesthesia, procedure and fluoroscopy.

Cutdown

Percutaneous


OVATION Post-Market Registry

2 Year Results of the multicenter, prospective, European post-market registry to evaluate the safety and performance of the Ovation® / Ovation Prime® Systems

Results as of January 8, 2016 based on investigator reported data. Data collected based on appropriate / available imaging modality.1Ns represent the number of completed follow-up visits for 1m, 1yr, and 2yr

Performance130 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)

Technical Success AllN=501

Successful, delivery and deployment of one aortic body and two iliac limbs 99.8%

Safety 0 to 30 DaysN=501

31 to 365 DaysN=499

366 to 730 DaysN=469

Rupture 0.2% 0% 0%

Conversion to Open Repair 0% 0.2% 0.4%

Freedom from AAA-Related Mortality 99.6% 99.6% 99.6%


OVATION® EUROPEAN

POST MARKET REGISTRY


Women had More Complex Anatomy Compared to Men

Anatomical Characteristics

12%

4% 4% 3%6%

38%

17%

9% 12%

2% 5%

65%

0%

10%

20%

30%

40%

50%

60%

70%

Neck dia ≥28mm Neck angle ≥60° Neck length<10mm

Severe neckcalcification

Severe neckthrombus

Min EIA dia <7mm

Men Women

Severe morphology based on SVS/AAVS anatomic scoring. Chaikof et al. J Vasc Surg 2002;35:1061-1066 / Walker et al. J Vasc Interv Radiol 2010;21:1632-1655


Men

N=432

Women

N=69

Technical Success* 99% 100%

Bilateral Percutaneous Access 39% 39%

Local Anesthesia 37% 40%

Minimal Blood Loss (100mL) 100% 100%

Median Length of Stay 4.0 days 4.0 days

Procedural Outcomes

*Two male technical failures involved inability to implant left iliac limb; both uni-iliac procedures completed successfully, one using fem-fem crossover and one using covered nitinol stent graft.


Men

N=432

Women

N=69

Type I/III Endoleak* 1.8% 0%

Conversion 0% 1.4%

Rupture 0.2% 0%

Aneurysm Enlargement ≥5mm 2.7% 2.5%

Freedom from Secondary Intervention 94% 88%

Freedom from AAA mortality 99% 100%

Freedom from All-Cause Mortality 96% 94%

Women and Men Derive Similar Outcomes at One Year

Ovation European Post Market Registry: Gender Analysis

Endoleak rate indicates presence of endoleak at one year imaging follow-up; endoleak treated within one year are reported within reintervention rate.One male contained rupture attributed to Type Ib endoleak and treated with hypogastric occlusion and iliac limb extension;One female conversion at 2 months due to stent graft thrombosis secondary to Type Ia endoleakAll data are site reported.


10. We Have Listened to Clinical Feedback – Ovation Alto

EVALUATON OF FEMALES WHO ARE UNDERREPRESENTED

CANDIDATES FOR ABDOMINAL AORTIC ANEURYSM REPAIR

LUCYUS Prospective Study225 patients / Up to 45 CentersEnrollment Q3 2016 to Q1 2017

LUCY EUEU Post Market Registry60 patients / Up to 12 EU CentersEnrollment to begin Q1 2017

*Projected enrollment completion


Ovation Alto

The Ovation Alto is not approved in any market; Ovation Alto is an investigational device in the United States, limited by federal (or United States) law to investigational use only. .

10. We Have Listened to Clinical Feedback – Ovation Alto

EXPANDING PATIENT APPLICABILITY WITH POLYMER SEALING OVATION ALTO STENT GRAFT

ELEVATE IDEUS FDA Pivotal Trial75 patients / Up to 12 CentersEnrollment to begin Q1 2017

ELEVATE2EU Post Market Registry300 patients / Up to 30 CentersEnrollment to begin Q3 2017

The Ovation Alto is not approved in any market; Ovation Alto is an investigational device in the United States, limited by federal (or United States) law to investigational use only. .

Clinical Evidence to Validate the Ovation Platform- Over 10,000 patients worldwide have been treated with Ovation

Abdominal Stent Graft platform, with over 1,500 subjects in a prospective study.

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

- Short term, low MAE rates, short hospitalization, and low hospital readmission rates.

- At 5 years, low rupture rate, and no conversions, Type I / III endoleaks or migrations, including stable aortic neck diameter

- Women derive similar benefits to men

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


Documents

OVATION: custom neck seal that benefits you and your patients,cacvsarchives.org/archivesite/2017/pdf/... · Consulting - TriVascular Employment in industry Shareholder in a healthcare