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Research In Brief

This article was originally published in The Gray Sheet

Executive Summary

SynCardia heart portable driver: Company has received conditional IDE approval to begin a study of its Freedom portable driver to power the CardioWest total artificial heart in bridge-to-cardiac-transplant patients. The trial, which will enroll 60 subjects, aims to demonstrate that stable CardioWest patients can manage their portable driver outside the hospital. According to SynCardia, a "major drawback" of existing technology is that patients are attached to a 418-pound driver and confined to the hospital while they await transplant. By contrast, the Freedom driver weighs 13.5 pounds and would enable patients to resume normal activities while awaiting a transplant, the firm says. The study will follow patients until transplant, 90 days after discharge, 90 days of Freedom support in the hospital or death. The Freedom driver received CE mark approval for use in Europe March 1

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