CIRCULATORY SUPPORT DEVICES PANEL Monday, March 4, 2002

3/1/02


Click here to start


Table of Contents

PPT Slide

CIRCULATORY SUPPORT DEVICES PANEL Monday, March 4, 2002

FDA REVIEW TEAM

PROPOSED EXPANDED INDICATION FOR USE

FDA MUST DETERMINE

DEVICE DESCRIPTION

PPT Slide

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

PPT Slide

PPT Slide

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

PPT Slide

Study Synopsis

PPT Slide

PPT Slide

PPT Slide

PPT Slide

PPT Slide

Adverse Events

PPT Slide

PPT Slide

Hospitalization Time

PPT Slide

PPT Slide

PPT Slide

First SAE or Death

Subsequent SAE or death

PPT Slide

Functional Status Summary

Statistical Summary

PPT Slide

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

PPT Slide

Labeling

Labeling

Labeling

Post-Market Evaluation

PPT Slide

Author: CDRH