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.
The Renu registry was designed as a non-randomized, single arm, prospective, postmarket registry of cases
involving the Zenith Renu AAA Ancillary Graft. The specific aims of the study are to1) obtain data on physician experience with the Zenith Renu AAA Ancillary Graft and 2 confirm device performance as measured by the absence of subsequent device-related problems.
Study Population Description
The Zenith Renu AAA Ancillary Graft from Cook Incorporated is indicated for secondary endovascular intervention
in patients having received prior endovascular repair of infrarenal abdominal aortic or aorto-iliac aneurysms. All cases entered into the registry will meet the following criteria: 1) Failed, existing non-Cook endograft, 2) Zenith Renu AAA Ancillary Graft, 3) Compliance with the intended use and implantation procedures described in the Renu IFU, 4) Registry data are de-identified with respect to patient.
100 patients, no site limit specified
Endpoints include: 1) Post-procedure (within 30 days of the procedure) rate of rupture and subsequent
death, 2) Post-procedure (within 30 days of the procedure) proximal attachment status (i.e., barb separation, stent fracture/breakage, position of the Zenith Renu AAA Ancillary Graft with respect to the fixation site and integrity of the seal with the aorta by the absence of a Type I endoleak as well as the pre-existing endovascular graft by the absence of a Type III endoleak), and 3) Post-procedure (within 30 days of the procedure) adverse events and re-interventions.
Followup Visits and Length of Followup
Data will be collecte pre-procedure, post-procedure within 30 days, at 12 months with clinical and
imaging follow-up, and telephone and imaging follow-up of adverse events and mortality annually up to five years.
Final Study Results
Actual Number of Patients Enrolled
Actual Number of Sites Enrolled
Patient Followup Rate
Final Safety Findings
One case of Renu migration occurred at 36 months after implantation. One occlusion was identified
at the 24-month time period.. Death beyond 30 days of the initial procedure occurred in 43 cases. Twenty-nine cases were determined to be unrelated to endovascular repair. Of the 14 remaining cases, 5 have been adjudicated as related to endovascular repair (i.e., procedure, technique, pre-existing graft, and/or Renu-related) and 9 are unable to be adjudicated due to insufficient information from the site (no additional information is able to be collected).
Final Effectiveness Findings
One hundred eleven (111) cases (73.5%) were identified with endoleaks prior to or during the
procedure. Of those cases with endoleaks, 96 were proximal type I endoleaks. There were 26 new type II endoleaks at one month and one remained at 60 months.
Study Strengths and Weaknesses
The sponsor reports that 91 patients reached an endpoint at 5 years. Although the follow-up
rate therefore is only 60%, there are enough patients with 5 year endpoint information since the conditions only required 100 patients to be enrolled.. The study provides additional information that can be used for updated labeling.
Recommendations for Labeling Changes
Yes. The labeling supplement should include a summary of the post-approval study design, results, and
study strengths and limitations. In addition, sponsor should provide not only rates in the revised labeling, but reasons for secondary interventions and conversions, as well as contributing factors or causes of death. Finally, the labeling should highlight the endoleak data from the post-approval study.