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BAXTER SUBMITS PREMARKET APPROVAL APPLICATION FOR HEART ASSIST SYSTEM

BAXTER SUBMITS PREMARKET APPROVAL APPLICATION FOR HEART ASSIST SYSTEM
 DEERFIELD, Ill., Feb. 25 /PRNewswire/ -- The Novacor Division of Baxter Healthcare Corp. announced today that it has submitted a premarket approval application (PMA) to the U.S. Food and Drug Administration (FDA) for the use of its N100 left ventricular assist system (LVAS) as a bridge to heart transplant.
 Baxter is the first company to submit a PMA for an electrically powered LVAS for this indication. The FDA will review Baxter's submission to determine if the N100 electronic pump, powered by an electrical console, is safe and effective for use in the United States.
 In clinical trials, the console-powered N100 system has been implanted as a "bridge" in 107 patients awaiting an acceptable donor for heart transplantation. The N100 system is the only electrically powered LVAS to have such extensive clinical experience, and only an electrical system will permit the achievement of a totally implantable LVAS.
 More than 300,000 Americans die every year due to irreversible heart failure. While heart transplantation is an effective therapy for many, only 2,000 donor hearts are available for transplantation each year in the United States.
 "The PMA submission for the N100 is truly a milestone in the field of ventricular assist systems," said Peer M. Portner, Ph.D., president of the Novacor Division. "If approved, the system will address a significant unmet clinical need by helping many patients who would otherwise die while waiting for a heart transplant. We are now one step closer to our ultimate goal -- the introduction of a totally implantable left ventricular assist system that can be used as a long-term alternative to heart transplantation."
 Data included in Baxter's PMA submission document more than 10 years of cumulative patient experience with the electrically powered system. The system has been studied in 20 clinical centers in the United States, France and Germany. Human clinical trials of the N100 system began at Stanford University Medical Center in 1984 with the world's first successful bridge-to-heart transplant. One St. Louis patient was on the N100 LVAS for more than a year before receiving a heart transplant.
 Novacor has been involved in the development of a totally implantable left ventricular assist system since 1969. The division has applied to the FDA for permission to begin clinical trials of a wearable LVAS. The Novacor wearable system will utilize the N100 electronic pump technology, along with a small battery and controller that can be worn around the patient's waist. Patients using an ambulatory system will have greater mobility and possibly be able to return home, improving their quality of life and reducing health-care costs substantially.
 Cardiovascular medicine is a primary research focus for Baxter. In addition to developing the Novacor LVAS, Baxter markets advanced oxygenators, cardiac catheters, heart valves and other leading cardiovascular devices.
 Baxter Healthcare Corp. is the principal U.S. operating subsidiary of Baxter International, Inc. (NYSE: BAX). Baxter, headquartered in Deerfield, is the leading manufacturer and marketer of health-care products, systems and services worldwide. The Novacor Division is located in Oakland, Calif.
 -0- 2/25/92
 /CONTACT: Linda Strauss of Novacor Division, 510-568-8338; Mary Curtin of Wang Associates, 212-685-1900, for Novacor; or Les Jacobson of Baxter Healthcare Corp., 708-948-4555/
 (BAX) CO: Baxter Healthcare Corp. ST: Illinois IN: MTC SU: AH -- NY055 -- 2392 02/25/92 13:34 EST
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Date:Feb 25, 1992
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