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SHILEY CALLS LETTER TO FDA UNNECESSARY IN VIEW OF PENDING SHILEY SETTLEMENT

 SHILEY CALLS LETTER TO FDA UNNECESSARY
 IN VIEW OF PENDING SHILEY SETTLEMENT
 NEW YORK, April 21 /PRNewswire/ -- The Shiley Heart Valve Research Center today called "unnecessary" a letter issued by the Public Citizen Health Research Group that asks the Food and Drug Administration to require Shiley to pay for surgery for people who want their Bjork-Shiley Convexo/Concave (C/C) valves replaced.
 Shiley said the letter is unnecessary because a class action settlement now pending before the U.S. District Court in Cincinnati provides reimbursement for valve replacement when the risk of such surgery is deemed appropriate compared to the risk of strut fracture. Under the terms of the settlement, when a court-approved medical panel recommends that categories of valves be considered for replacement, candidates for surgery would not have to bear any of their own surgical or related medical costs.
 The HRG letter is based on data that appeared in The Lancet Feb. 1, 1992. On April 10, 1992, FDA sent Shiley a letter directing that physicians and people with valves be provided additional information about the heart valves. Shiley is in the process of preparing appropriate communications to valve recipients and physicians.
 FDA's letter focuses on large size (29mm or larger) 60-degree C/C mitral valves welded prior to June 30, 1982. The letter concludes that for these valves, the rate of fracture is higher than previously reported.
 Shiley has been working for some time with FDA, the medical community and independent expert panels comprised of cardiologists and cardiothoracic surgeons on the valve replacement issue.
 For a substantial majority of 60-degree C/C valve recipients, the recently published information in The Lancet does not suggest an important difference in risk compared to earlier reports.
 Roger Sachs, M.D., president of the Shiley Heart Valve Research Center, said: "Shiley believes that the procedures set forth in the settlement agreement are the responsible way to deal with the many complex factors relating to any reoperation in order to avoid enc of Pfizer Inc. (NYSE: PFE).
 -0- 4/21/92
 /CONTACT: Robert Fauteux, 714-250-8446, or Rick Honey of Pfizer, 212-573-2051, both for Shiley/
 (PFE) CO: Shiley Incorporated; Pfizer Inc. ST: New York IN: MTC SU:


CK -- NY033 -- 0513 04/21/92 10:26 EDT
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Publication:PR Newswire
Date:Apr 21, 1992
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