ShockWave receives FDA breakthrough device designation for Coronary IVL System
Shockwave Medical announced that the company has received Breakthrough Device Designation from the U.S. Food and Drug Administration for its Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter, which is currently the subject of an Investigational Device Exemption study called DISRUPT CAD III. The Shockwave C2 IVL Catheter is a proprietary tool designed to fracture problematic calcium using sonic pressure waves in order to facilitate stent delivery, deployment and optimal expansion, thereby improving blood flow to the heart muscle. DISRUPT CAD III is a prospective, non-randomized, multicenter global IDE study to demonstrate the safety and effectiveness of the Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter in de novo, calcified, stenotic, coronary arteries prior to stenting. The study is approved to enroll 442 patients at 50 centers in the United States and Europe, and is led by co-principal investigators Drs. Dean Kereiakes and Jonathan Hill. As reported in the company's second quarter earnings call, the study had enrolled 108 patients as of June 30, 2019. Shockwave C2 Coronary IVL catheters are commercially available for the treatment of de novo coronary artery disease in Europe and select other geographies; they are limited to investigational use in the United States.