SynCardia Systems has received approval from the U.S. Food and Drug Administration for the first temporary artificial heart for use in patients with end-stage congestive heart failure. The Tucson, Ariz.-based company's CardioWest Temporary Total Artificial Heart will serve as an in-hospital bridge to transplantation for patients at imminent risk of death. It is the first FDA-approved temporary total artificial heart and will be used for patients who are likely to die within 30 days due to nonreversible biventricular failure. Marvin Slepian, president and chief executive officer of SynCardia, called the approval a "significant milestone in medical history." -- by Michael Romano
Temporary artificial heart receives FDA approval
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