Table of Contents
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CIRCULATORY SUPPORT DEVICES PANEL Monday, March 4, 2002
FDA REVIEW TEAM
PROPOSED EXPANDED INDICATION FOR USE
FDA MUST DETERMINE
DEVICE DESCRIPTION
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PRECLINICAL EVALUATION Determined To Be Satisfactory
PRECLINICAL EVALUATION Remaining Concerns
RELIABILITY PROTOCOL Bench Testing
RELIABILITY RESULTS Bench Testing
RELIABILITY RESULTS Bench Testing
PREDICTED RELIABILITY Bench Testing
OBSERVED END OF PUMP LIFE Clinical Trial
OBSERVED DEVICE MALFUNCTIONS Clinical Trial
ENGINEERING SUMMARY
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Expanded Indication for Use
Primary Effectiveness Endpoint
Study Design Assumptions
Inclusion Criteria Original Criteria (124/129 pts)
Inclusion Criteria **Later Criteria (5/129 pts)**
Exclusion Criteria
Baseline Characteristics (p >.05)
Study Design
Survival
Serious Adverse Events
Comparison of Destination and Bridge Therapy SAE’s
Serious Adverse Events Neurological Dysfunction
Serious Adverse Events Local Infections
Serious Adverse Events Sepsis
Serious Adverse Events Percutaneous/Pocket Infections
Serious Adverse Events Pump Housing, Inflow, Outflow Infections
Serious Adverse Events Bleeding
Serious Adverse Events Perioperative Bleeding
Serious Adverse Events Operations (all types, after original implant)
Device Malfunction Analysis
Withdrawal from Treatment
Secondary Endpoints
NYHA Class Results
Quality of Life Results
Quality of Life (Number of Patients Tested)
6 minute Hall Walk (number of tests performed)
6 minute Hall Walk
Peak VO2 (ml/kg/min)
Peak VO2 (ml/kg/min)
Hospitalization
Death During Initial Hospitalization
Clinical Summary
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Study Synopsis
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Adverse Events
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Hospitalization Time
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First SAE or Death
Subsequent SAE or death
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Functional Status Summary
Statistical Summary
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Questions for the Panel P920014/S16
Device Reliability
Device Reliability
Data Analysis
Effectiveness of the System on Functional Status
Risk-Benefit of the System used for Destination Therapy
Labeling
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Labeling
Labeling
Labeling
Post-Market Evaluation
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