ultra low-profile EVAR: experience and future vision STEVE HENAO MD New Mexico Heart Institute Albuquerque, New Mexico
Ovation PRIME™ Abdominal Stent Graft Suprarenal nitinol stent with integral anchors for fixation Tri-modular design Low-viscosity, radiopaque, fill polymer 13-14F OD conformable iliac limbs
14F OD main body Inflatable rings for optimal seal
Novel Design Paradigm 20Fr OD
Other Stent Graft
14Fr OD
Ovation Prime Stent Graft
The Ovation Prime Aortic Body eliminates stent / material overlap which allows for significant reduction in profile without compromising durability Note: Images show graphical representation of a stent graft
Anatomical Characteristics Minimum Access Vessel Diameter (n=159)* 52% of Enrollment
50
• Over 50% of patients treated had minimum access vessel 5mm 1Technical
30 Day
1 Year
2 Years
3 Years
Baseline
98%
96%
86%
Success based on investigator reports Adverse Events, Device Related MAE and All Cause Mortality 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), 423/30 CTs available for analysis @ 3 years (4 pts expired, 3 CTs unavailable for AAA diameter assessment). Type II endoleaks reported in 2/3 AAA enlargements @ 3 years. 2Major
OVATION Post Market Registry A multicenter, prospective, post-market study to evaluate study to evaluate the safety and performance of the TriVascular Ovation and Ovation Prime Abdominal Stent Graft System. 500 subjects were enrolled at 30 sites across Europe. All (N=496)
Technical Success Defined as successful, delivery and deployment of one aortic body and two iliac limbs
99.6%
Treatment to 30 Days (N=500)
31 to 365 Days (N=485)
Freedom from Rupture
99.8%
100%
Freedom from Conversion to Open Repair
100%
99.8%
Safety
30 Day (N=454)
6 months (N=339)
1 Year (N=233)
2 Year (N=47)
Freedom from Type I and III Endoleaks
98.7%
99.1%
98.7%
100%
Freedom from Migration
100%
100%
100%
100%
Freedom from Iliac Occlusion
99.6%
99.7%
100%
100%
Aneurysm Assessment
30 Day (N=422)
6 months (N=264)
1 Year (N=192)
Freedom from Enlargement >5mm
Baseline
97.7%
99.0%
Performance
1Results
as of December 17, 2013 based on investigator reported data. Ns represent the number of completed follow-up visits for 1m, 6m, 1yr, and 2yr. 2Analysis windows are: 6 months (91 to 304 days) and 1 year (305 to 547 days)
Heavy Calcification No aortic neck growth at 2 years
Pre-case
Post-30 day
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. 830-0182-01rA
Case Studies From Ovation Global Pivotal Study Demonstrate Stable Aortic Neck Diameters
Post 2-year 13
The Ovation and Ovation Prime Clinical Experience §
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Over 3000 patients worldwide have been treated by Ovation and Ovation Prime Abdominal Stent Graft Systems, with 25% of the experience in a tightly controlled study or registry §
161 patients have been enrolled in the Ovation Global Pivotal Study
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77 patients have been enrolled in the Ovation Continued Access Study
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500 patients have been enrolled in the OVATION Post Market Registry
Patient demographics, anatomical characteristics, and procedural characteristics indicate a challenging patient cohort Worldwide commercial experience mirrors the excellent clinical results achieved to date Ultra-low profile results in: § less trauma § less bleeding § less complications § less patient discomfort
