Medstone's STS Lithotriptor
This article was originally published in The Gray Sheet
Firm suffers setback in long-standing bid to commercialize the first lithotriptor for fragmenting biliary stones with FDA's decision not to approve the firm's September 1997 combination premarket approval application/supplemental new drug application. In April, FDA's Gastroenterology and Urology Devices Panel had recommended that FDA approve the device, which in combination with Novartis' Actigall (ursodiol) anti-gallstone drug is intended to fragment and clear the function of the gall bladder of symptomatic, radiolucent, non-calcified stones 4-20 mm in diameter. The device already is approved for fragmenting kidney stones
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