low profile EVAR

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 <7mm in diameter
• Smallest vessel diameter treated = 3.2mm
38
25
13
0
<6 mm
Aortic Neck Length (n=161)*
50
29% of
Enrollment
38
• Nearly 1/3 of patients treated
had a neck length of <15 mm
6 - 6.9 mm 7 - 7.9 mm 8 - 8.9 mm 9 - 9.9 mm >9.9 mm
25
13
0
<10
10-14.9
15-19.9
*Based on core lab reported measurements
20-29.9
30-39.9
40-49.9 >49.9 mm
Worldwide Commercial Experience
As of July 31, 2013, almost 2,000 patients had been treated with the Ovation and Ovation Prime Abdominal
Stent Graft Systems worldwide.
United States
(N=335)
Outside the US
(N=1612)
(October 5, 2012 – July 31, 2013)
(August 17, 2010 – July 31, 2013)
Rupture
0.0%
0.1%
Aneurysm Enlargement
0.0%
0.0%
AUI
0.3%
0.1%
Open Surgical Repair
0.3%
0.4%
0.0%
0.1%
Type Ia
0.3%
0.6%
Type Ib
0.0%
0.1%
Type III
0.0%
0.1%
Aortic Body
0.0%
0.0%
Iliac Limb
0.6%
0.2%
Stent
0.0%
0.1%
Graft
0.3%
0.1%
0.0%
0.2%
Reported Event Type*
Conversion
Migration
Endoleak
Device Occlusion
Device Integrity
Aneurysm-related Death
*Rates from manufacturer data submitted to FDA for Annual Report
Global Pivotal Study
A pivotal clinical study to evaluate the safety and effectiveness.
161 patients were enrolled in Chile, Germany, and USA.
All
(N=161)
Technical Success
Defined as successful, delivery and deployment of one aortic body and two iliac limbs
100%
Treatment to 30 Days
(N=161)
31 to 365 Days
(N=159)
366 to 730 Days
(N=154)
Freedom From Major Adverse Events
97.5%
96.2%
Not Reported
Freedom From Device Related Major Adverse Events
100%
100%
Not Reported
Freedom from Rupture
100%
100%
100%
Freedom from Conversion to Open Repair
100%
100%
100%
Safety2
Effectiveness
30 Day
1 Year
2 Years
(N at follow-up interval)
(N at follow-up interval)
(N at follow-up interval)
100% (153)
100% (143)
100% (120)
Freedom from Migration
Baseline
100% (150)
100% (132)
Aneurysm Assessment
30 Day
1 Year
(N=150)
2 Years
(N=131)
Baseline
98.7%
96.2%
Freedom from Type I and III Endoleaks
Freedom from Enlargement >5mm
1Technical
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),
4Type II endoleaks reported in all cases of AAA Enlargement. Analysis windows are: 1 year (305 to 547 days) and 2 years (548 to 911 days)
2Major
EU Cohort @ 3 Years
A pivotal clinical study to evaluate the safety and effectiveness of the TriVascular Ovation Abdominal Stent
Graft System. Results for the 30 patients were enrolled in Germany.
All
(N=161)
Technical Success
Defined as successful, delivery and deployment of one aortic body and two iliac limbs
30 Day
Safety
100%
1 Year
(N at follow-up interval)
(N at follow-up interval)
Freedom from Type I and III Endoleaks
0%
10% (3)
Freedom from Migration
0%
0%
Effectiveness
30 Day
1 Year
2 Years
3 Years
Freedom from Type I, III, and IV Endoleak
100%
100%
100%
100%
Freedom from Migration
100%
100%
100%
100%
Freedom from Conversion to Open Surgical Repair
100%
100%
100%
100%
Freedom from Aneurysm Rupture
100%
100%
100%
100%
Aneurysm Assessment
Freedom from Enlargement >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)
Straightforward
No aortic neck growth at 4 years
Pre-case
Post-30 day
Post 4-year
Reverse Tapered Neck
Pre-case
Post-30 day
©2013 TriVascular, Inc. All Rights Reserved.
No aortic neck growth at 2 years
Post 2-year
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
§
§
§
§
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
§
77 patients have been enrolled in the Ovation Continued Access Study
§
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
Other Future Implications
§
Conscious Sedation + Local Anesthesia
§ Outpatient EVAR
§ Percutaneous rEVAR
16
ultra low-profile
EVAR:
experience and future vision
STEVE HENAO MD
New Mexico Heart Institute
Albuquerque, New Mexico