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BAXTER ANNOUNCES FDA APPROVAL OF TWO ARTIFICIAL HEART VALVES

     BAXTER ANNOUNCES FDA APPROVAL OF TWO ARTIFICIAL HEART VALVES
    DEERFIELD, Ill., Dec. 3 /PRNewswire/ -- The Edwards CVS Division of Baxter Healthcare Corp. today announced Food and Drug Administration approval of two artificial heart valves -- the Carpentier-Edwards(R) Pericardial Bioprosthesis valve and the Carpentier-Edwards Duraflex(TM) Low Pressure Fixed Bioprosthesis valve.
    The Carpentier-Edwards Pericardial valve is the first new artificial heart valve approved for use in the United States in five years.  The Duraflex valve is the only low-pressure mitral tissue valve available in the United States.
    The new devices -- bioprostheses, or tissue valves -- are beneficial to elderly patients because, unlike mechanical valves, they can eliminate the need for long-term anticoagulant drug therapy.
    In 1990, 55,000 Americans, most over the age of 55, underwent surgery to replace degenerated heart valves.  Stenosis and valve insufficiency, caused by diseases such as rheumatic fever, calcification and congenital abnormalities, can lead to the replacement of the aortic or mitral heart valves -- the major valves that control blood flow between the heart's chambers.
    Carpentier-Edwards Pericardial Bioprosthesis.
    "The Carpentier-Edwards Pericardial Bioprosthesis performs more like the valve you were born with than other pericardial valves," says Robert Frater, M.D., chief of cardiothoracic surgery at Montefiore Medical Center, New York.  "The weak points of the design of past pericardial valves have been eliminated, allowing for the development of a more durable valve with improved hemodynamics.  The improved design is a great advance for frail elderly and other patients with a small aortic root."
    The Carpentier-Edwards Pericardial valve is made of bovine pericardial tissue, the thin membrane surrounding the heart of a cow. It is made specifically for use in the aortic position and is the only pericardial valve available in the United States.
    Baxter engineers used advanced computer-modeling technology to create the valve's unique structure and shape.  This design increases valve flexibility and durability, while decreasing tissue abrasion.
    During clinical trials, the Carpentier-Edwards Pericardial valve was studied in 719 patients at 10 medical centers nationwide.
    At eight years of follow-up, 95 percent of patients remained free of structural valve deterioration.
    Carpentier-Edwards Duraflex Low Pressure Fixed Bioprosthesis.
    The Duraflex valve has been used safely in patients for more than eight years.  The valve was approved after meeting revised heart valve review standards established by the FDA in 1986.
    All tissue heart valves like the Duraflex undergo a pressure fixation process to stabilize the tissue and preserve important valve structures.  Baxter has developed and introduced a unique low-pressure fixation process that helps maintain the original tissue structure. This preserves the valve's flexibility and shock-absorbing qualities. These attributes are important in the mitral position because of the high stresses placed on the mitral valve during left-ventricular contraction.  Low-pressure fixation has shown good results in the laboratory, and it is hoped that this new tissue-fixation process will result in a more durable bioprosthetic valve.
    "The Carpentier-Edwards Duraflex valve demonstrates better hemodynamics than the mitral tissue valves currently available to surgeons," say D. Craig Miller, M.D., professor of cardiovascular surgery at Stanford University.  "Low-pressure fixation has produced a valve that opens more fully and is more supple.  Theoretically, low- pressure fixation will increase the valve's durability."
    "The introduction of the Carpentier-Edwards Pericardial and Duraflex valves demonstrates Baxter's continued leadership in cardiovascular technology," says Wilbur H. Gantz, Baxter's president.  "We are investing heavily to bring new, lifesaving cardiovascular products to market."
    The world's first artificial heart valve, introduced in 1960, was developed by Baxter scientists and partners in Portland, Ore.  Since then, more than 600,000 Baxter heart valves have been implanted in patients worldwide.  Baxter's Novacor Division has developed an implantable heart assist device, which is currently undergoing clinical trials in the United States and Europe.
    Edwards CVS Division, based in Irvine, Calif., manufactures and markets a complete line of biological and mechanical prostheses and related instruments for cardiovascular surgery.
    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.
    -0-        12/3/91
    /CONTACT:  Suzanne Latimer of Edwards CVS Division, 714-250-3615; Les Jacobson of Baxter Healthcare, 708-948-4555/
    (BAX) CO:  Baxter Healthcare Corp. ST:  Illinois IN:  MTC SU: SH -- NY067 -- 8837 12/03/91 14:32 EST
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Publication:PR Newswire
Date:Dec 3, 1991
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