Shockwave Completes Enrollment in Pivotal Study for Coronary Intravascular Lithotripsy

Shockwave Medical, Inc. (NASDAQ: SWAV) announced today that the company has completed enrollment in the pivotal U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) study – DISRUPT CAD III – for the use of IVL in heavily calcified coronary arteries. The investigational Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter, which has been granted Breakthrough Device Designation by the FDA, is an innovative therapy designed to fracture problematic calciu m using sonic pressure waves in order to facilitate stent delivery, deployment and optimal expansion.
Source: News from Angioplasty.Org - Category: Cardiology Source Type: news