Shockwave has completed the DISRUPT BTK clinical study, demonstrating the effectiveness and safety of IVL in small diameter, difficult-to-treat BTK arteries - no procedural complications, low residual stenosis and no TLR at 30 days in severely calcified CLI patients.
But, right now we're in the early phases of the R&D program. In the meantime, don't miss the IVL application that heart teams are embracing already — maintaining transfemoral TAVR access through heavily calcified iliacs by using IVL.
Too bad our coronary technology is not yet approved in the United States. Good news is that we have initiated our U.S. FDA IDE study. Learn more about the Disrupt CAD III study on our clinical research portion of the website.