Transcription of IFU 00001 Rev 05 - HeartWare
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IFU 00001 Rev 05 - HeartWare
HeartWare Ventricular assist System Instructions for Use Caution: Federal law restricts this device to sale by or on the order of a physician. HeartWare Ventricular assist System Instructions for Use i TABLE OF CONTENTS INTRODUCTION .. 1 INDICATIONS FOR USE .. 2 CONTRAINDICATIONS .. 2 WARNINGS .. 2 PRECAUTIONS .. 6 POTENTIAL COMPLICATIONS .. 8 CLINICAL TRIAL RESULTS .. 9 PIVOTAL CLINICAL STUDY DESIGN .. 9 STUDY OBJECTIVES .. 9 STUDY POPULATION DEMOGRAPHICS AND BASELINE PARAMETERS .. 9 SAFETY AND EFFECTIVENESS RESULTS .. 11 OVERALL CONCLUSIONS FROM CLINICAL DATA .. 24 SYSTEM COMPONENT OVERVIEW .. 24 HeartWare VENTRICULAR assist SYSTEM.
HeartWare® Ventricular Assist System Instructions for Use 2 2.0 INDICATIONS FOR USE The HeartWare® Ventricular Assist System is indicated for use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure.
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