U.S. Cautious on Valve Implant Tester: The...
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From Times Staff and Wire Reports
U.S. Cautious on Valve Implant Tester: The government wants more tests before approving a device designed to detect potential life-threatening defects in mechanical heart valves made by Irvine-based Shiley Inc. Illinois scientist Gerald A. Kien contends that a computerized device he invented can detect changes in the sound of a Shiley heart valve about to fracture inside a patient. A Food and Drug Administration official said the agency fears premature approval could lead to doctors performing surgery to replace good heart valves.
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