DISRUPT CAD III Meets all Endpoints in U.S. Pivotal Study for Coronary Intravascular Lithotripsy

The Shockwave Coronary IntraVascular Lithotripsy (IVL) System has been available in Europe for more than 2 years, but to receive U.S. approval, it needed to show safety and efficacy in a trial specifically designed to meet FDA requirements. Today the 30-day results of the DISRUPT CAD III were presented by Dr. Dean Kereiakes at TCTConnect, the online virtual version of the annual Transcatheter Cardiovascular Therapeutics meeting, and the device met all endpoints, moving it closer to approval for the U.S. market.
Source: News from Angioplasty.Org - Category: Cardiology Source Type: news