Transcription of CLINICAL STUDY SUMMARY ENABLE MRI - Boston …
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CLINICAL STUDY SUMMARY ENABLE MRI - Boston …
CAUTION: Federal Law restricts this device to sale by or on the order of a physician trained or experienced in device implant and follow-up procedures. CLINICAL STUDY SUMMARY ENABLE MRI TABLE OF CONTENTS CLINICAL STUDY SUMMARY OF ENABLE MRI CLINICAL STUDY .. 1 STUDY DESIGN .. 1 METHODS .. 1 Subject Selection .. 1 Inclusion and Exclusion Criteria .. 1 Inclusion Criteria .. 1 Exclusion Criteria .. 2 ENABLE MRI STUDY Endpoints .. 3 Safety Endpoint .. 3 Effectiveness Endpoints .. 3 RESULTS .. 3 Subject Demographics .. 4 STUDY Endpoint Results .. 5 Safety Endpoint Results .. 5 Effectiveness Endpoints Results .. 6 ADVERSE EVENTS SUMMARY .. 10 DEATH SUMMARY .. 11 CONCLUSION .. 11 The following are trademarks of Boston Scientific Corporation or its affiliates: AUTOGEN, DYNAGEN, IMAGEREADY, INOGEN, and STUDY SUMMARY OF ENABLE MRI STUDY | 1 DESIGN CLINICAL STUDY SUMMARY OF ENABLE MRI CLINICAL STUDYThe ENABLE MRI CLINICAL STUDY was designed to collect data to confirm the safety and effectiveness of the ImageReady MR Conditional Defibrillation System (hereafter referred to as the ImageReady System) when used in the MRI
CAUTION: Federal Law restricts this device to sale by or on the order of a physician trained or experienced in device implant and follow-up procedures. CLINICAL STUDY SUMMARY
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