Shock-Wave Lithotripsy

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Abstract
Just two years ago the first device designed to fragment kidney stones with shock waves generated outside the body was delivered to the United States by its German manufacturer, Dornier Systems. Soon, six American centers were participating in premarketing trials. Within 10 months, during which American experience corroborated German results,1 the Food and Drug Administration approved the Dornier device for marketing in the United States. FDA approval was announced with much fanfare; the secretary of Health and Human Services participated along with the FDA administrator and hailed extracorporeal shock-wave lithotripsy as "an authentic modern miracle," certain to enhance the quality . . .

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