PMA Review Team

2/28/02


Click here to start


Table of Contents

PPT Slide

PPT Slide

PMA Review Team

Regulatory History

Regulatory History

Medtronic InSync? ICD Model 7272 System Components

Model 7272 Preclinical Testing

Software Validation

Attain? Model 4189 LV Lead Preclinical Testing

PPT Slide

Indications for Use

PPT Slide

Study Design

Timing of Testing

Maintenance of the Blind

Effectiveness

Primary Safety Objectives

Secondary Objectives

Inclusion Criteria

Exclusion Criteria

Patient Accountability

Patient Accountability

Blinding Issues and Crossovers

Baseline Characteristics

Primary Safety Objectives

Quality of Life Results

PPT Slide

Quality of Life Overall Assessment

NYHA Class Results

Change in NYHA Classification from Baseline to 6 months

6 minute Hall Walk Results (meters)

PPT Slide

6 minute Hall Walk Results 6 months

Effectiveness

Primary Endpoint: LV Lead Effectiveness

Secondary Objectives: Peak VO2 (ml/kg/min)

Secondary Objectives

Secondary Objectives

Secondary Objectives

Mortality

PPT Slide

Coronary Sinus Trauma

Adverse Events: Observations

Additional Issues Associated with ICD function

Percentage of Time BiV Paced

Programming Issues: Device-Device Interaction and Limitations

Programming Issues: Device-Device Interaction and Limitations

PPT Slide

PPT Slide

Study Design and Analysis Method

Study Design and Analysis Method

Study Design and Analysis Method

Effectiveness of the System in Treating CHF

Effectiveness of the System in Treating CHF

Safety of the System in Treating CHF

Effectiveness of the System as an ICD

Safety of the System

Safety of the System

Risk-Benefit of the System for Treatment of CHF

Labeling

Labeling

Labeling

Post-market Study

PPT Slide

Author: Gerry Gray