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THERMO CARDIOSYSTEMS FILES PROTOCOL WITH U.S. FDA TO RELEASE PATIENTS FROM HOSPITAL

 THERMO CARDIOSYSTEMS FILES PROTOCOL WITH U.S. FDA TO RELEASE
 PATIENTS FROM HOSPITAL
 WOBURN, Mass., July 14 /PRNewswire/ -- Thermo Cardiosystems Inc. (AMEX: TCA) has submitted a protocol for the U.S. Food and Drug Administration's (FDA) review. Under the terms of this protocol, patients being supported with the company's portable electric HeartMate(R) ventricular-assist device (VAD) would be allowed to leave the hospital while they await transplantation, as long as they meet the protocol requirements. Under the terms of the protocol, the patients could move into a nearby home or apartment, provided they stay within a reasonable distance of the hospital. The company is also preparing a similar protocol for patients with the original, air-driven version of the HeartMate VAD, which is currently being considered by the FDA for commercial approval.
 Under separate Investigative Device Exemptions from the FDA, the company's VADs are used to support patients whose own hearts are no longer strong enough to sustain life while they await transplantation. Clinical trials of the electric HeartMate VAD are under way at the Texas Heart Institute at St. Luke's Episcopal Hospital in Houston. Two patients at this prestigious transplant center are currently being supported with this battery-powered HeartMate system. One of the patients has been supported by the electric HeartMate for 101/2 months. This portable device allows patients an unprecedented degree of mobility while they await transplantation.
 "All we are doing is giving these patients three meals a day and a bed to sleep in," said Dr. O. Howard Frazier, director of cardiothoracic surgery at the Texas Heart Institute. "Most patients could just as well be at home with their families, leading normal lives while they wait for donor hearts."
 "These patients are doing extremely well," said Victor L. Poirier, president of Thermo Cardiosystems. "Our system is very simple to operate, and the patients have demonstrated that they can take care of the HeartMate system themselves. I see no reason for them to remain in the hospital." The company believes these devices may one day provide an alternative to heart transplantation.
 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 Inc. is a public subsidiary of Thermedics Inc. (AMEX: TMD) and Thermo Electron Corporation (NYSE: TMO).
 -0- 7/14/92
 /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:


SH -- NE005 -- 8984 07/14/92 09:36 EDT
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Publication:PR Newswire
Date:Jul 14, 1992
Words:449
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