Medical Device Registries: Multiple Applications

1. Medical Device Registries: Multiple Applications Thomas P. Gross, MD, MPH Director Division of Postmarket Surveillance Office of Surveillance & Biometrics Center for Devices & Radiological Health AHRQ Annual Conference Registries for Evaluating Patient Outcomes Bethesda, Md. September 9, 2008

2. Registry as a Vehicle:Regulatory Applications Pre- & Postmarket Safety &/or Effectiveness Discretionary & Mandatory Surveillance & Observational Study Descriptive & Analytic

3. Registries: Premarket PerspectivePotential Applications • Provide data to support development & design of clinical trials • Provide historical comparator data (if rigorous) • Enhance safety assessments via broader analysis of adverse events • Provide access to product (outside of IDE trial) • Expedite approval of device modifications or labeling

4. Registries: Premarket PerspectiveSafety Assessment Adhesion Barrier Device Registry • Voluntary, European experience, 4K patients • Adjunct to U.S. pivotal, randomized trial • Assess safety profile • Self-reported events, “reassuring” profile

5. Registries: Premarket PerspectiveProduct Access PFO Occluder Device Registry • Withdrawal of Humanitarian Device Exemption status • Submission of Premarket Approval Applications required (supported by clinical trials) • Access to device for those outside of clinical trials • Voluntary, U.S., 2K patients

6. Registries: Premarket PerspectiveDevice/Labeling Changes Intra-ocular Lens Registry • Assess performance of IOLs in adults < 60 years • Established by American Academy of Ophthalmology • Post-IOL acuity & adverse events on 7K eyes • Indications changed allowing for younger age use

7. Registries: Postmarket PerspectivePotential Applications • Provide surveillance for “real-world” events • Assess generalizability of new technologies • Expedite time to market with reliable postmarket data • Provide vehicle for Post-approval Studies (PAS) • Promote evidence development for CMS’ national coverage decisions (NCDs)

8. INTERMACS: Enhanced Surveillance

9. INTERMACS: Post-approval Studies • Provides the necessary infrastructure • Patient consent, IRB sign-off, data acquisition & quality • Is cost efficient & allows for enhanced oversight • Accommodates different study designs • Temporary total artificial heart: single-arm registry; 30-day & 1 year survival, time on device, transplant rates, adverse events & product problems • Left ventricular assist device: cohort design (recipients of designated device vs. concurrent recipients of other LVADs); similar outcome measures & including quality of life

10. Registries: Postmarket PerspectiveEarly “Real-World” Experience & PAS Drug-eluting Coronary Stent Registry • Assess “real-world” experience • Multiple sites (~50), 2K patients • Sites vary by private/academic, implanting volume, geographic distribution • Outcomes of interest: MACE, unanticipated events • Descriptive findings • Periodic follow-up at 1, 6, 12 months

11. Registries: Postmarket PerspectiveFDA PAS & CMS NCD Carotid Stent Registry • Carotid Stents: Initial • Vehicle for post-approval study • Assess “real-world” experience & training (3 levels) • Multiple sites, 1K patients, 30-day follow-up • Adjudicated neurological events • Carotid Stents: Extension • Expand under CMS coverage • Explore risk factors associated with stenting • Multiple sites, 10K patients, 30-day follow-up

12. Registries: Postmarket PerspectiveDiscretionary Study Hemostasis Device Registry • Collaborative effort with American College of Cardiology (use of National Cardiovascular Data Registry) • ~60 sites, 14K patients • Assess gender differences & device-specific risk of hemorrhagic complications

13. Registries: From a Disease Perspective • Toxic Anterior Segment Syndrome (TASS) • Non-infectious inflammation post-surgery (mostly cataract removal) • Results in blurred vision to glaucoma or corneal transplant • Outbreaks periodically reported • Device relatedness is an issue • viscoelastics? • surgical instruments? • Registry maintained at University of Utah & cases also accrued via ASCRS website • Augment TASS registry with spontaneous reports & assess utility for identifying suspect causative agents

14. FDA Registry Initiatives • Expand existing registries • National ICD registry (ACC NCDR & HRS): add lead safety fields (lead revision, extraction, abandonment & reasons for failure) • Conduct linkage studies with Medicare data • Society of Thoracic Surgeons National Cardiac Database: study long-term morbidity & mortality of transmyocardial revascularization • ACC NCDR: study long-term cardiac morbidity & mortality of drug-eluting coronary stents

15. FDA Registry Initiatives • Compare registry performance • Medicare claims vs. prospectively collected registry data from the Vascular Disease Study Group of Northern New England • Morbidity & mortality associated with endovascular vs. open surgical repair of abdominal aortic aneurysm • Nest investigational study within registry • Uses PAS to expand indications • Rigorous investigational study design

16. FDA Registry Initiatives Sentinel Initiative*: an effort to develop a national, integrated infrastructure of electronic healthcare data systems for medical product safety surveillance • Identify & characterize existing U.S. orthopedic implant registries. Explore potential for establishing distributed system. *http://www.fda.gov/oc/initiatives/advance/sentinel

17. Thanks for Your Attention! For further information: thomas.gross@fda.hhs.gov