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

Transcription

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

2 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

3 EVAR Path to Durable Sealing

4 EVAR Path to Durable Sealing

5 EVAR Path to Durable Sealing IFU

6 Endurant Excluder Zenith % Patients within FDA IFU* 69% 55% 50% 47% 45% Neck Length Neck Angle Non-traditional requirement Refer to neck length 60 if neck length 10mm 45 if neck length <10mm 15mm 10mm 15mm 15mm 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 mm Profile (OD) 14F 19F 18F 20F 21F

7 Ultra Low Profile Path to Durability with a Patient-Specific Seal Staged deployment of suprarenal stent allows precise placement 14F OD ultra low profile enables access to more patients Conformable, kink resistant PTFE iliac limbs designed to reduce risk of occlusion Polymer-filled sealing ring creates a custom seal and protects the aortic neck Low permeability PTFE enables effective aneurysm exclusion and device patency

8 Ovation Platform Broadens Applicability, on-ifu Endurant Excluder Zenith % Patients within FDA IFU* 69% 55% 50% 47% 45% Neck Length Neck Angle Non-traditional requirement Refer to neck length 60 if neck length 10mm 45 if neck length <10mm 15mm 10mm 15mm 15mm 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 mm Profile (OD) 14F 19F 18F 20F 21F

9 You Do Need an Aortic Neck to Achieve Seal CONVENTIONAL NECK REQUIREMENT Based on Neck segment 10mm or 15mm of parallel vessel wall OVATION NECK REQUIREMENT Custom Seal Area: neck diameter 16 mm and 30 mm at 13mm below inferior renal (IR) artery / landing area Parallel vessel wall along length of sealing zone Circumferential seal occurs at midpoint of sealing ring at IR+13

10 Ovation Platform Custom Seals to the Patients Anatomy 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 Liquid polymer injected to inflate O-ring Liquid polymer cures to a solid, durable state Non-expansive circumferential wall apposition of sealing ring creates no chronic outward radial force and no aortic neck dilatation

11 Ovation Platform Custom Seals to the Patients Anatomy

12 Ovation and Challenging Distal Anatomy

13 Ovation Platform Clinical Compendium Over 10,000 patients worldwide have been treated with the Ovation Abdominal Stent Graft Platform, with over 1,500 patients in a prospective study 161 patients 501 patients 250 patients 285 patients 375 patients Ovation Global Pivotal IDE Ovation EU Post Market Registry 36 Centers US, Chile, Germany 5 Year Results 30 Centers 3 Year Results FAST Track EVAR 40 Centers 30d Results US 30 Centers EU 12 Centers Enrolling Alto IDE and PMR Enrollment starting in 2017

14 Least Invasive Fast-Track (LIFE) EVAR Registry 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: Percutaneous Access No General Anesthesia No ICU Admission Next-day Discharge

15 No Device- or Procedure-Related Major Adverse Events LIFE Fast-Track PEVAR EVAR 0.4% (1/250) 0.5% (1/216) 1 0% (0/26) 0% (0/8) 1 MAE non-device nor procedure-related: death due to acute respiratory failure 28 days post procedure As of August 2, 2016

16 30d Hospital Readmissions 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 LIFE readmission rate is 5x less than contemporary EVAR reports EVAR ACS NSQIP Gupta 2014 EVAR ACS NSQIP Chen 2016 LIFE Registry EVAR Cases (N) Time Period Unplanned 30d Readmission 7.9% 8.1% 1.6% Operation during Readmission 28% - 0% ACS NSQIP: American College of Surgeons National Surgical Quality Improvement Program Chen SL et al. Perioperative Risk Factors for Readmission Following EVAR. Presented at SCVS, Gupta PK, et al. Unplanned readmissions after vascular surgery. J Vasc Surg 2014;59:

17 Ovation Global Pivotal Trial Ovation Global Pivotal IDE 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 United States Chile Germany 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 Kasirajan, Karthik Krajcer, Zvonimir Laird, John Maini, Brijeshwar Makaroun, Michel Maldonado, Thomas Mehta, Manish Mishkel, Gregory Moore, Wesley Motew, Stephen Murkherjee, Dipankar Rizvi, Adnan Sternberg, Charles UAB Emory University St. Luke s Hospital UC Davis Moffitt Heart and Vascular UPMC NYU Hospital Albany Medical Center Prairie Heart UCLA Forsyth Medical Center Inova Fairfax Hospital Minneapolis Heart Institute Ochsner Health System Valdes, Francisco Catholic University Brunkwall, Jan Krankenberg, Hans Mathias, Klaus Nolte, Thomas Scheinert, Dierk Sievert, Horst Torsello, Giovanni Uni. Klinik Ko ln Medizinisches Versorgungszentrum, HH Klinikum Dortmund Herz und Gefa ßzentrum, Bad Bevensen Park Krankenhaus, Leipzig CVC, Frankfurt St. Franziskus-Hospital, Münster

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

19 Safety and Effectiveness Ovation Global Pivotal IDE Lowest Reported MAE Rate Across IDE Trials for FDA-Approved AAA Devices Ovation IDE Endurant IDE Zenith IDE Excluder IDE Patients Enrolled / 100 Std Risk / High Risk 565 ASA Class III/IV 60% / 7% 49% / 0% NR NR Major Adverse Event 0-30d / d 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% Results for EVAR commercially available devices shown per the respective US FDA Summary of Safety and Effectiveness Data (SSED) and Annual Clinical Reports.

20 Freedom from Mortality through 5 Years 98% Five Year Freedom from ARM 75% Five Year Freedom from ACM Ovation Global Pivotal IDE

21 Ovation Global Pivotal Trial Case Study Example No Type 1 endoleak and stable neck diameter 1 Neck Length 2 (Core lab measurement): 4mm Pre-Case Pre-Deployment Post-Deployment 3 Year Follow-Up Ovation Global Pivotal IDE 1 Core 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 renals 2 Physician measurement of at least 7mm neck length in pivotal trial Images are courtesy Manish Mehta, MD, Albany Medical Center, Albany NY

22 Adjunctive Procedures for Type Ia Endoleak Pivotal IDE LIFE Registry EU PMR Adjunctive Procedures For intra-operative Type Ia endoleak 3.1% 3.2% 0.6% 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.

23 Type Ia Endoleak Intervention through 5 Years 97% Five Year Freedom from Reintervention for Type 1 Endoleak Ovation Global Pivotal IDE

24 Freedom from Reintervention through 5 years 97% for type I endoleak 97% for occlusion 90% for type II endoleak 81% for all reintervention Ovation Global Pivotal IDE

25 Aortic Neck Dilatation through 5 Years Ovation Global Pivotal IDE CONVENTIONAL EVAR EVAR WITH OVATION Core lab results show stable neck diameter through 5 years 1 Monahan JVS 2010: 52: N=46. Devices: Cook Zenith 2 Rodway EJVES 2008;35: EVAR: N=67, Open N=56. Data to 2 years. 3 Core Lab evaluation, Ovation Global Pivotal Trial. N=94. Data as of Aug 2, Neck dilation = growth > 3mm at 10mm, 13mm, and 15mm below renals

26 OVATION EUROPEAN POST MARKET REGISTRY Multicenter, prospective 501 patients, 30 EU sites Enrolled May 2011 December 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

27 Baseline Characteristics Ovation EU Post Market Registry Patient demographics and comorbid risk factors indicate a typical AAA patient cohort. 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)

28 Anatomical Characteristics Ovation EU Post Market Registry 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: / Walker et al. J Vasc Interv Radiol 2010;21:

29 Procedural Outcomes Ovation EU Post Market Registry In the Ovation study, subjects undergoing percutaneous access achieved similar clinical outcomes with slightly lower time spent related to anesthesia, procedure and fluoroscopy. 40% Percutaneous 60% Cutdown 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 30 Days 3.3% (3/92)

30 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 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= to 365 Days N= to 730 Days N=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% Performance 1 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

31 OVATION EUROPEAN POST MARKET REGISTRY

32 Anatomical Characteristics Women had More Complex Anatomy Compared to Men 70% Men Women 65% 60% 50% 40% 38% 30% 20% 10% 0% 12% 17% 9% 12% 4% 4% 3% Neck dia 28mm Neck angle 60 Neck length <10mm 2% Severe neck calcification 6% 5% Severe neck thrombus Min EIA dia <7mm Severe morphology based on SVS/AAVS anatomic scoring. Chaikof et al. J Vasc Surg 2002;35: / Walker et al. J Vasc Interv Radiol 2010;21:

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

34 Ovation European Post Market Registry: Gender Analysis Women and Men Derive Similar Outcomes at One Year 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% 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 endoleak All data are site reported.

35 10. We Have Listened to Clinical Feedback Ovation Alto EVALUATON OF FEMALES WHO ARE UNDERREPRESENTED CANDIDATES FOR ABDOMINAL AORTIC ANEURYSM REPAIR LUCY US Prospective Study 225 patients / Up to 45 Centers Enrollment Q to Q LUCY EU EU Post Market Registry 60 patients / Up to 12 EU Centers Enrollment to begin Q *Projected enrollment completion

36 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..

37 10. We Have Listened to Clinical Feedback Ovation Alto EXPANDING PATIENT APPLICABILITY WITH POLYMER SEALING OVATION ALTO STENT GRAFT ELEVATE IDE US FDA Pivotal Trial 75 patients / Up to 12 Centers Enrollment to begin Q ELEVATE2 EU Post Market Registry 300 patients / Up to 30 Centers Enrollment to begin Q 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..

38 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