Medical Device Registries: Multiple Applications (Text Version)

Slide Presentation from the AHRQ 2008 Annual Conference

On September 9, 2008, Thomas P. Gross, M.D., M.P.H, made this presentation at the 2008 Annual Conference. Select to access the PowerPoint® presentation (216 KB).

Slide 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

Slide 2

Registry as a Vehicle: Regulatory Applications

The slide shows an image of a driver in a car with a large cloud of smoke containing:

• Pre- & Postmarket
• Safety &/or Effectiveness
• Discretionary & Mandatory
• Surveillance & Observational Study
• Descriptive & Analytic

Slide 3

Registries: Premarket Perspective Potential 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 Investigational Device Exemption [IDE] trial).
• Expedite approval of device modifications or labeling.

Slide 4

Registries: Premarket Perspective Safety 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.

Slide 5

Registries: Premarket Perspective
Product 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.

Slide 6

Registries: Premarket Perspective
Device/Labeling Changes

Intra-ocular Lens (IOLs) 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.

Slide 7

Registries: Postmarket Perspective
Potential 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 the Centers for Medicare & Medicaid Services' (CMS) national coverage decisions (NCDs).

Slide 8

INTERMACS: Enhanced Surveillance

Slide 9

INTERMACS: Post-approval Studies

• Provides the necessary infrastructure:
  • Patient consent, Institutional Review Board (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 (LVAD): cohort design (recipients of designated device vs. concurrent recipients of other LVADs); similar outcome measures & including quality of life.

Slide 10

Registries: Postmarket Perspective Early "Real-World" Experience & Patient Assessment Survey (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.

Slide 11

Registries: Postmarket Perspective Food and Drug Administration (FDA) 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.

Slide 12

Registries: Postmarket Perspective
Discretionary 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.

Slide 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 American Society of Colon and Rectal Surgeons (ASCRS) Web site.
• Augment TASS registry with spontaneous reports & assess utility for identifying suspect causative agents.

Slide 14

FDA Registry Initiatives

• Expand existing registries:
  • National ICD registry (American College of Cardiology National Cardiovascular Data Registry [ACC NCDR] & Heart Rhythm Society [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.

Slide 15

FDA Registry Initiatives (continued)

• 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.

Slide 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

Slide 17

Thanks for Your Attention!

For further information: thomas.gross@fda.hhs.gov