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
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