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THERMO CARDIOSYSTEMS ISSUES PROGRESS REPORT

 THERMO CARDIOSYSTEMS ISSUES PROGRESS REPORT
 WOBURN, Mass., May 1 /PRNewswire/ -- The following is a progress


report issued by Thermo Cardiosystems Inc. (AMEX: TCA):
 Thermo Cardiosystems Inc. manufactures two versions of its HeartMate(R) ventricular-assist devices (VADs): an air-driven version and a portable, battery-powered version. As of April 10, 1992, there were 11 patients in the United States being supported by HeartMate VADs Q nine by the air-driven system and two by the electric. This is the largest number of patients we have ever had on the device simultaneously Q yet another indication of the acceptance our technology is receiving from cardiac opinion leaders around the country. FDA Commercial Approval Sought for Air-driven HeartMate VAD
 On March 30, 1992, the company submitted a premarket approval application to the U.S. Food and Drug Administration to market the air-driven VAD throughout the United States. This submission was the culmination of six years of clinical trials representing implants in 70 patients and, in its final form, filled 10,000 pages.
 Currently, 16 different transplant centers in the United States are approved by the FDA to use our system on an investigational basis only. Once we have received market approval, we will be able to market the HeartMate device to any of the more than 150 heart transplant centers in the United States.
 An FDA response could take as long as 12 to 18 months. During this time, our clinical sites will continue to perform implants and evaluate the air-driven device. We will also submit requests to increase the number of transplant centers that are approved by the FDA to use our systems. Electric HeartMate VAD Supporting Two Patients
 Clinical trials of the company's battery-powered HeartMate VAD have been under way since the first implant was performed in May 1991. There have been four implants of the device to date. Two patients are currently being supported by the device at the Texas Heart Institute at St. Luke's Episcopal Hospital in Houston. One of these patients has been supported by the portable system for more than seven months, the other for just over a month. In the other two cases, patients died from causes unrelated to the performance of the pump. The Sunday magazine supplement to the Houston Post recently ran a cover story featuring Mike Templeton, the patient who has been supported for seven months. The article describes Michael's activities around the hospital, how he feels with the electric system, and how he manages to carry on with his personal life.
 This summary is one in a series of periodic updates issued by Thermo Cardiosystems Inc. to report on the company's progress with ongoing clinical investigations of its HeartMate ventricular-assist device.
 -0- 5/1/92
 /CONTACT: John N. Hatsopoulos of Thermo Cardiosystems, 617-622-1111/
 (TCA) CO: Thermo Cardiosystems, Inc.; Thermo Electron Corporation ST: Massachusetts IN: MTC SU:


SH -- NE006 -- 5415 05/01/92 10:52 EDT
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Publication:PR Newswire
Date:May 1, 1992
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