February 1, 1985

FDA approves lithotripter for kidney stone shattering

JAMA. 1985;253(5):620-623. doi:10.1001/jama.1985.03350290018003

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The Food and Drug Administration has approved an ultrasonic kidney stone shattering device (JAMA [MEDICAL NEWS] 1983;249:2434-2435).

This version of the device, technically called a lithotripter, was recommended for approval last May after extensive review of the clinical data by the FDA's advisory panel on gastroenterological and urological devices. The FDA commissioner acted on this advice just before the new year.

This lithotripter has been used in treating some 10,000 patients with kidney stones in studies over the past five years in West Germany, as well as in several centers in the United States over the last year and a half. Currently, six centers in the United States have the device. The lithotripter was originally developed in West Germany by Dornier System of Friedrichshafen.

The FDA has approved the lithotripter for treating stones formed in the renal calyx, pelvis, and upper third of the ureter. It is not suitable for