Medical Device Registries: Multiple Applications

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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

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Registry as a VehicleRegulatory Applications
Pre- Postmarket Safety /or
Effectiveness Discretionary Mandatory
Surveillance Observational
Study Descriptive Analytic
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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

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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

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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

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Registries Premarket PerspectiveDevice/Labeling
Changes

• Intra-ocular Lens Registry
• Assess performance of IOLs in adults lt 60 years
• Established by American Academy of Ophthalmology
• Post-IOL acuity adverse events on 7K eyes
• Indications changed allowing for younger age use

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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)

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INTERMACS Enhanced Surveillance
FDA Reports INTERMACS
Complete information No Yes
Validated data No Yes
Adjudicated data No Yes
Standard definitions No Yes
Representative No We hope so
Under-reported Yes We hope not
Denominator data No Yes
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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

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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

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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

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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

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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

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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

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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

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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/sentine
  l

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Thanks for Your Attention!
For further information thomas.gross_at_fda.hhs.gov