CorCap CSD

1

• CorCap CSD
• Condition of Approval Study
• Brock Hefflin, MD, MPH
• Epidemiology Branch/Office of Surveillance and
  Biometrics
• Circulatory System Devices Panel Meeting
• June 22, 2005

2
CoA Studies General Principles

• Objective is to surveil or evaluate over an
  extended period, after premarket establishment of
  reasonable device safety and effectiveness,
  device performance and potential device-related
  problems
• Purpose does not include the evaluation of
  unresolved issues from the premarket phase that
  are important to the initial establishment of
  device safety and effectiveness

3
Sponsors Proposed CoA Study Summary

• Design 5-year surveillance of up to 348 patients
  with CorCap CSD
• Variables NYHA class, mortality, adverse events,
  echo measurements
• Inclusion criteria similar to pivotal clinical
  trial
• Components group from PCT plus 2 new groups
• Data combined, stratified by study variables,
  submitted to FDA in annual report

4
Assessment of Proposed CoA Study

• Comparison group
• Subject of question 14 to the Panel
• Clinical outcomes meaningful differences
• -need to be proposed
• -rationale to support
• Prevalent heart disease etiology representation
• Subject of question 15 to the Panel