CE Mark approval for Lithoplasty balloon catheter for PAD-Shockwave Medical
Shockwave Medical has announced EU CE Mark regulatory approval for the company�s Lithoplasty balloon catheters for the treatment of Peripheral Artery Disease (PAD). The application for the CE Mark for Lithoplasty was supported by safety and utility clinical data from the multicenter DISRUPT PAD study, which was presented in November 2014 at the Vascular Interventional Advances (VIVA) Annual Conference in Las Vegas, Nevada. Early results demonstrated safe and effective dilatation of calcified stenosis with no acute failures, very favorable residual stenosis, no major adverse events and no restenosis out to 30 days.
Unlike current devices that treat only superficial calcium, Shockwave�s Lithoplasty system is designed to be effective on all types of calcium, including deep � the type known to limit vessel expansion. It is delivered on a standard balloon catheter platform.
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