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FDAnews Device Daily Bulletin

Shockwave Announces Positive Data for Lithoplasty System

April 28, 2016

Shockwave Medical has released positive results from its DISRUPT PAD study evaluating its Lithoplasty system for the treatment for peripheral artery disease.

The system met its primary endpoint of achieving less than 50 percent residual stenosis with or without adjunctive angioplasty.

The device — which uses intermittent pulsatile mechanical energy for arterial calcification — received CE marking for treating peripheral vascular disease.

The data were presented at the Charing Cross 2016 symposium in London. The device is not for sale in the U.S. — Anisa Jibrell

 

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