Ovation 4-Year Results Pivotal Study to Evaluate the Safety and Effectiveness of the Ovation System

Transcription

1 Ovation 4-Year Results Pivotal Study to Evaluate the Safety and Effectiveness of the Ovation System Vascular Health Partners Glens Falls, New York

2 Disclosure Speaker name: I have the following potential conflicts of interest to report: Other Principal Investigator, US Global Ovation Pivotal Trial

3 Limitations of Conventional EVAR 1 = Unmet Clinical Needs 1 Morrison T, Fillinger M, Meyer C, et al. Gender disparities in endovascular treatment options for infrarenal abdominal aortic aneurysms. erences/ucm pdf. Published June 25, Nearly 35% of men and 60% of women remain ineligible for EVAR Inadequate neck length was a main driver of ineligibility Limitations based on narrow access vessels Treatment options limited to surgical repair, fenestrated / branched endografts, off-label EVAR, or watchful waiting

4 Persistent EVAR Challenges Characteristics of Hostile Access Anatomy Narrow (<6mm) Occluded Tortuous Calcified Aneurysmal Narrow Access Vessels 5.3 mm 3.2 mm Access Vessel Tortuosity 40% Patients < 6mm M2S Database 43,000 CT Scans 55% Female Patients <6mm (CHAP) Collaborative effort 1,063 CT Scans

5 Persistent EVAR Challenges Characteristics of Hostile Neck Anatomy Short Aortic Necks (<15mm) Reverse Tapered Necks Calcium Thrombus Severe Angulation Large Diameter Reverse Tapered Necks At Inferior Renal Artery At IR + 5 At IR + 13 Calcium/Thrombus lined Necks 48% Patients < 15mm Necks* M2S Database 43,000 CT Scans 63% Women < 15mm Necks** (CHAP) Collaborative effort 1,063 CT Scans

6 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 5

7 Ovation Global Pivotal Trial Investigator Valdes, Francisco Investigator Brunkwall, Jan Krankenberg, Hans Mathias, Klaus Nolte, Thomas Scheinert, Dierk Sievert, Horst Torsello, Giovanni Site Catholic University Site Uni. Klinik Ko ln Medizinisches Versorgungszentrum, HH Klinikum Dortmund Herz und Gefa ßzentrum, Bad Bevensen Park Krankenhaus, Leipzig CVC, Frankfurt St. Franziskus-Hospital, Münster 161 patients enrolled in Chile, Germany and USA First Global IDE Trial Broadest Indication Statement Included First-In-Man at all sites Investigator Botti, Charles Cheema, Mohiuddin Clair, Daniel Eidt, John Eskandari, Mark Glickman, Mark Gray, Bruce Haser, Paul Hassoun, Heitham Henretta, John Hodgson, Kim Jain, Ash Jicha, Douglas Jones, Paul 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 Site Riverside Methodist Hospital Hartford Hospital Cleveland Clinic Central Arkansas VA Northwestern Memorial Sentara Medical Group Greenville Hospital UMDNJ Methodist Hospital Mission Hospital Southern Illinois University Washington Hospital Santa Rosa Memorial Mercy Medical Center 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

8 Ovation Global Pivotal Trial Subject Demographics Age (Yrs) Mean ± std 73 ± 8 Gender Male % (n/n) 87.6% (141/161) 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)

9 Ovation Global Pivotal Trial Baseline Aortoiliac Characteristics Mean ± SD Min, Max Aortic diameter 13mm below renal artery (mm) ± , 32.3 Juxtarenal angle (degrees) ± , 60.0 Proximal neck length (mm) ± , 50.0 Aortic aneurysm diameter (mm) ± , 90.0 Aortic bifurcation diameter (mm) ± , 53.5 Left iliac diameter (mm) ± , 34.0 Left iliac minimum access diameter (mm) ± , 11.5 Right iliac diameter (mm) ± , 23.4 Right iliac minimum access diameter (mm) ± , % (66/161) of Ovation Trial patients treated had access vessels <6mm, aortic neck length <10mm, or both. Neither Criteria 59% Access Vessel <6mm, 25% Both Criteria 8% Neck Length 8% 1 Data provided by site imaging 2 Data provided by imaging core lab

10 Ovation Global Pivotal Trial 4-year results of the global pivotal clinical study to evaluate the safety and effectiveness of the TriVascular Ovation Abdominal Stent Graft System. Technical Success 1 Safety 2 0 to 30 Days N= to 365 Days N= to 730 Days N= to 1095 Days N= 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% All N=161 Defined as successful, delivery and deployment of one aortic body and two iliac limbs 100% Effectiveness 3 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) Data as of July 31, Technical Success based on investigator reports 2 Major 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 3 Endoleaks and Migration rates based on Core Lab Data (M2S)

11 Ovation Global Pivotal Trial 120 Aneurysm Diameter Stable or Decreasing 3 and 4 year Rates TriVascular Ovation (U.S.) Cook Zenith High Risk Cook Zenith Standard Risk Endologix XL Endologix Infrarenal Bifurcated 3-year 4-year Endologix Suprarenal Aortic Ext. Endologix Suprarenal Bifurcated Gore Excluder Medtronic Endurant US Ovation study subjects had an aneurysm enlargement rate at 4 years of 10.0% which is comparable to previous EVAR studies that only included US subjects (range 2.1% %). All Ovation study subjects with aneurysm diameter enlargement had a type II endoleak reported by the core lab during one or more follow-up visits. No AAA ruptures or conversions have been reported through 4 years

12 Ovation System Expands EVAR Key Indications Proximal Neck Length Proximal Neck Angle (Degrees) Neck Diameter Iliac Diameter Device Features Profile OD (main body) TriVascular Ovation Cook Zenith Flex Endologix AFX Gore Excluder C3 Lombard Aorfix Medtronic Endurant II No conventional neck length 15mm 15mm 15mm 15mm 10mm requirement 1 <60 if neck length 10 mm 45 if neck length < 10 mm 16-30mm Inner Wall 8-25mm 3 Inner Wall 60 for infrarenal neck 45 degrees for suprarenal neck 18-32mm Outer Wall mm Outer Wall < mm Not Specified 10-23mm Not Specified 19-32mm Inner Wall 8-25mm Inner Wall 19-33mm Inner Wall mm Inner Wall mm Inner Wall 8-25mm Inner Wall 14F-15F 21F-23F 19F 20F 22F 18F-20F *Device Indications from Company Instructions for Use 1 In Ovation pivotal trial, neck length indication of 7mm 2 In healthy landing zones. Measurement is outer wall to outer wall in diseased landing zones. 3 Ovation ix Iliac Stent Graft System

13 Ovation System Improves EVAR Safety & Effectiveness Rates at 1-year TriVascular Ovation IDE Cook Zenith Flex IDE Endologix PowerLink IDE Sources: Ovation data as of June 6, 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: Includes re-interventions on Day 0. Gore Excluder Combined IDE Lombard Aorfix IDE Medtronic Endurant IDE Patients Enrolled Major Adverse 24.3% / Not Event 2.5% / 3.8% Not Reported 6.3% / 18% 18.6% / 17.1% Reported 0-30 / days All-Cause Mortality 0-30 / days 0.6% / 1.9% 0.5% / 3.0% 1.6% / 5.2% 1.0% / 7.0% 1.8% / Not Reported 4.0% / 6.5% 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 Rupture 1 0% 0% 0% 0% 0.5% 0.8% Conversions 1 0% 1% 2.1% 1.1% 1.8% 0% Freedom from 99.3% 98.7% 97.8% 95.0% 98.8% 100% Sac Enlargement Limb Occlusions 1 1.2% 3.0% 3.1% 0.4% 3.7% 2.7% Subjects Requiring Reinterventions 6.2% 11.0% 9.9% 11.5% 15.6% 6.7% 2 1

14 Ovation System Well Suited for Percutaneous Access Access Type 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. Cut-Down Percutaneous Percutaneous 43% Cut-down 57% Major Adverse 30 Days 3.3% (3/92) 1.4% (1/69) Treatment 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 Cut-down Percutaneous

15 Proximal Neck diameter average expansion (mm) Ovation System Protects the Aortic Neck Ovation Global Pivotal study demonstrates encouraging results with stable neck diameter and durable seal through 4 years: Sealing ring technology creates no chronic outward radial force. Aortic Neck Dilatation Over Time* Self-Expanding Stents Open Repair Ovation System 3,4 Baseline 1 Year Growth 2 Year Growth 3 Year Growth 4 Year Growth *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 Trial 3,4. 1 Monahan JVS 2010: 52: N=46. Devices: Cook Zenith 2 Rodway Eur J Endovasc Surg 2008; 35: EVAR: N=67, Open: N=56. Data available for up to 2 years. 3 Core Lab evaluation, Ovation Global Pivotal Trial. N=94. Data as of July 31, Neck dilation in proximal neck defined as growth > 3mm at 10mm below renals, 13mm below renals, and 15mm below renals

16 Clinical Evidence to Validate Ovation System Advantages Over 8,000 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 diameters. These data provide compelling evidence that the Ovation system can expand EVAR access to more patients and improve EVAR outcomes for all patients

17 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.

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