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THERMO CARDIOSYSTEMS SUBMITS CARDIAC-ASSIST DEVICE FOR FDA REVIEW

THERMO CARDIOSYSTEMS SUBMITS CARDIAC-ASSIST DEVICE FOR FDA REVIEW
 WOBURN, Mass., March 31 /PRNewswire/ -- Thermo Cardiosystems Inc. (AMEX: TCA) has submitted to the U.S. Food and Drug Administration (FDA) a premarket approval (PMA) application to begin commercial distribution of the air-driven HeartMate(R) left ventricular-assist device (VAD).
 The air-driven device, since first implanted in 1986, has been used in more than 70 patients at various transplant centers around the country. The safety and effectiveness data collected during these clinical trials will be evaluated by the FDA in considering commercial approval of the air-driven HeartMate system.
 The company is developing an electrically-powered version of the HeartMate VAD that provides patients with even more mobility. The battery-powered system, which is being evaluated under an Investigative Device Exemption granted by the FDA last year, has been used in four patients to date.
 The HeartMate VADs are designed to support the pumping function of the patient's natural heart rather than replace it. Currently, these devices are being used in bridge-to-transplant applications. The company cannot sell its VADs commercially in the United States until it receives FDA approval of its PMA application.
 Thermo Cardiosystems Inc. is a leader in research and development of implantable ventricular-assist devices. These devices are designed to perform substantially all or part of the pumping function of the left ventricle of the natural heart for patients suffering from cardiovascular disease. The company's devices are currently intended for investigational use only. Thermo Cardiosystems is a public subsidiary of Thermedics Inc. (AMEX: TMD) and Thermo Electron Corporation (NYSE: TMO).
 -0- 3/31/92
 /CONTACT: John N. Hatsopoulos of Thermo Cardiosystems, 617-622-1111/
 (TCA TMD TMO) CO: Thermo Cardiosystems Inc.; Thermo Electron Corporation ST: Massachusetts IN: MTC SU:


EG -- NE002 -- 3588 03/31/92 16:44 EST
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Publication:PR Newswire
Date:Mar 31, 1992
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