U.S. Cautious on Valve Implant Tester: The...
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.
More to Read
Start your day right
Sign up for Essential California for news, features and recommendations from the L.A. Times and beyond in your inbox six days a week.
You may occasionally receive promotional content from the Los Angeles Times.