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U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies

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AneuRx Stent Graft System

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Study Status Completed
522 Number / Requirement Number PS010001 / PSS001
Date Current Plan Accepted 04/26/2002
Study Name AneuRx Stent Graft System
Root Document Number P990020 
General Study Protocol Parameters
Study Design Prospective & Retrospective Study
Data Source Sponsor Registry
Comparison Group Historical Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Prospective observational cohort study to examine aneurysm-related mortality through long term follow-up
Study Population Description Adult

Sample Size 19 sites

Data Collection Primary endpoint: Aneurysm-related mortality

Follow-up Visits and Length of Follow-up 5 year length of follow-up; visits scheduled annually

Interim or Final Data Summary
Actual Number of Patients Enrolled 931

Actual Number of Sites Enrolled 19

Patient Followup Rate 100%
Final Safety Findings There are no statistically differences in freedom from death, rupture or surgical conversion between the registries and the IDE cohort. The rate for freedom from surgical conversaion in the registry is 95.7% and for IDE is 89.9%. Freedom from death in the registry is 78.4% and IDE is 71.8% Freedom of ARD in registry is 97.9% and the IDE is 96.9%. The rate of freedom fro surgical conversaion at four years in the registry is 98.6% and the IDE is 91.3%

Final Effectiveness Findings The delivery success rate was 99.4% for the registry compared to 98.1% in IDE. Endoleak in the registry was significantly lower intra-operatively than for the IDE study. But for all subsequent time periods, there was no statistically significant difference between the IDE and the registry. For the increases in aneurysm diameter, except for the first year that the PS registry demonstrated significantly higher rates of increases in aneurysm diameter. No difference was found in subsequent years between IDE and registry. In terms of loss of device integrity, there was no difference between the results from IDE and the registry.

Study Strengths and Weaknesses Strengths: Prospective study; National Death Index (NDI) used to achieve follow-up of vital status and cause of death on patients who were otherwise lost to f/u; Sufficiently large sample size, and good variety of different sites

Weakness: No concurrent control group

Recommendations for Labeling Changes Recommended labeling change to reflect ARM results

  • The 522 Postmarket Surveillance Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated under section 522 of the Federal Food, Drug and Cosmetic Act. The program helps ensure that well-designed 522 postmarket surveillance (PS) studies are conducted effectively and efficiently and in the least burdensome manner.
  • In May 2008, the oversight responsibility of the 522 Postmarket Surveillance 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). DEPI continues to build the 522 program.
  • CDRH has established an automated internal tracking system that efficiently identifies the reporting status of active 522 PS studies 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 522 PS 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 522 PS study. The webpage displays general information regarding each study, as well as the overall study status (based on protocol-driven timelines and adequacy of the data) and the applicant's reporting status for each submission due.


Contact Information

Cheryl Reynolds
Project Manager, 522 Postmarket Surveillance (PS) Studies Program
Food and Drug Administration
10903 New Hampshire Ave
Silver Spring, MD 20993-0002

Phone: (301) 796-6068
Fax: (301) 847-8140