Sound Evidence for Your Coronary Calcium Strategy

Single-arm, pre-market European study demonstrating the safety and performance of IVL in heavily calcified, coronary lesions prior to stenting and followed to 6 months; also included an OCT Sub-study demonstrating IVL’s mechanism of action.

Post-market, European registry examining the ongoing safety and performance of coronary IVL in heavily calcified coronary lesions up to 30 days in more centers and more patients.

A prospective, multicenter, single-arm, investigational device exemption (IDE) study to evaluate the safety and effectiveness of the Shockwave Coronary IVL System taking place in the United States, United Kingdom, Germany and France. The goal of this study is to generate the data needed to obtain FDA approval for use of coronary IVL in the United States.

A prospective, multicenter, single-arm study intended to support regulatory device approval in Japan by investigating the safety and effectiveness of coronary IVL. Caution: In Japan coronary IVL is limited to investigational use within the DISRUPT CAD IV Study.