Introduction and Background

2/28/02


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Table of Contents

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Agenda

Introduction and Background

Introduction

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InSync Study Primary Endpoints*

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InSync Primary Safety Results Summary

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Study Design, Methodology and Patient Population

Entry Criteria

InSync ICD Study Design

Timing of Baseline Tests

Study Features to Maintain the Blind

Primary Safety Objectives

Secondary Safety Objectives

Lead Effectiveness Objectives

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Primary Effectiveness Endpoints

Secondary Effectiveness Endpoints

Study Milestones

Patient Disposition

Patient Disposition

Patient Disposition

Methodology Overview

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Patient Demographics

Patient Demographics

Safety Results

Primary Safety Objectives

Secondary Safety Objectives

Lead Effectiveness Objectives

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Lead Placement and LV Venous Anatomy

Adverse Event Definitions

Implant Success

Unsuccessful Implants (n=50)

Adverse Events During the Implant Procedure

Resolution of Adverse Events During the Implant Procedure

Resolution of Implant Dissection/Perforation Events

Primary Safety Objective 1: Freedom From InSync ICD Related Complications at 3 Months

Freedom From InSync ICD Related Complications at 3 Months

Primary Safety Objective 2: Freedom From Attain Model 4189 LV Lead-Related Complications at 6 Months

Freedom From Attain Model 4189 LV Lead-Related Complications at 6 Months

Attain Model 4189 LV Lead Related Complication Event Resolution

Primary Safety Objective 3: Freedom From Attain Model 2187/2188 LV Lead-Related Complications at 6 Months

Freedom From Attain Model 2187/2188 LV Lead-Related Complications at 6 Months

Primary Safety Objective 4: InSync ICD System-Related Complications at 6 Months

Primary Safety Results: Summary

Secondary Safety Results

Spontaneous VT/VF Therapy Effectiveness

VT/VF Episodes Control vs. CRT Patients Completing 6 Months of Follow-up

ATP Efficacy During Spontaneous VT

Ventricular Defibrillation Testing

Lead Effectiveness Results

Lead Effectiveness Objective 1: Implant Success Results

Lead Effectiveness Objective 2: Attain Model 4189 LV Lead Pacing Threshold Performance

Voltage Pacing Threshold for Attain Model 4189 LV Leads

Lead Effectiveness Objective 3: Attain Model 2187/2188 LV Lead Pacing Threshold Performance

Voltage Pacing Threshold for Attain Model 2187/2188 LV Leads

Effectiveness Results

Primary Efficacy Endpoints

Change in Quality of Life Score

Change in NYHA Functional Class

Change in NYHA Functional Class

Change in 6-Minute Hall Walk Distance

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Secondary Effectiveness Results

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Secondary Effectiveness Results: Clinical Endpoints

Exercise Performance Peak VO2 and Exercise Duration

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Secondary Effectiveness Results: Physiological Variables

Change in Echo Parameters

Change in Echo/ECG Parameters

Change in Neurohormone Levels

Comparison of InSync and InSync ICD

InSync ICD Study Design

Timing of Baseline Tests

Comparison of Patient Demographics InSync and InSync ICD

Comparison of Patient Demographics InSync and InSync ICD

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The End