In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).
The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.
In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.
A prospective, consecutively enrolling, single-arm, non-randomized, multi- center study
Study Population Description
Patients with abdominal aortic aneurysm with vascular morphology suitable for endovascular repair with the Ovation/Ovation
Prime Abdominal Stent Graft System. Eligible patients must have met or must meet all of the inclusion criteria and none of the exclusion criteria.
Patients will be categorized into those treated by physicians
¿ who completed fewer than 20 endovascular repairs of AAA with any endovascular graft in the 2 years preceding participation in the Ovation physician training program, and those
¿ who completed 20 or more cases in the preceding 2 years.
A total 320 subjects comprises of 161 pivotal cohort subjects, all continued access subjects, all
subjects from the HDE PAS and at least 59 de novo subjects enrolled from a minimum of 15 U.S. sites.
¿ Technical failure
¿ Type 1 endoleak
¿ Use of Accessory device
Through 30 days
¿ Serious Adverse Events (SAEs)
¿ Mortality (AAA-related and
¿ Device Patency
¿ Conversion to open surgical repair
¿ AAA enlargement
¿ Stent Graft Migration
¿ Device integrity
¿ Secondary endovascular procedures
¿ Aneurysm rupture
Followup Visits and Length of Followup
At implant and 30 days
Final Study Results
Actual Number of Patients Enrolled
Actual Number of Sites Enrolled
Patient Followup Rate
100% at 30 days
Final Safety Findings
Final Effectiveness Findings
Endpoint results for physicians with fewer than 20 prior endovascular repairs and physicians with
more prior endovascular repair in 2 years preceding participation in Ovation/Ovation Prime Training Program were as follows: Technical failure 0% for both physician groups, Type 1 endoleak 0% vs. 0.7% (95% CI for difference: -3.4%, 4.7%), and Use of Accessory devices 0.0% vs.8.9% (95% CI for difference:
2.6%, 15.2%), respectively.
Through 30 days post Implant
The adverse events rates for physician with fewer than 20 endovascular repairs and physicians with 20 or more endovascular repair in 2 years preceding participation in Ovation/Ovation Prime Training Program were as follows: AAA-related secondary endovascular procedures 0% vs. 1.0%, device-related SAEs 0% vs. 1.3%, and renal events (including acute kidney injury, renal insufficiency, renal failure) 0% vs. 1.7%, respectively. No statistically significant differences were observed between the 2 groups for any adverse event. The rates for thromboembolic events, paralysis/paraparesis, stroke, claudication and ischemic colitis were 0% in both physician groups.
Study Strengths and Weaknesses
The study achieved the target enrollment of 320 patients with 100% follow-up at 30days and
a high technical success. Patient enrollment in the physicians with fewer than 20 prior endovascular experience group was low.
Recommendations for Labeling Changes
Labeling change is recommended to reflect the Training Program evaluation data from the post-approval study.
The labeling change should include a new section on the label showing a summary of the post- approval study methods (including study objectives, design, population, number of enrolled
sites/subjects, key endpoints, follow –up visits etc.), final results and study strengths and limitations of the PAS.