Sound Evidence for Your Coronary Calcium Strategy

At Shockwave, we’re committed to the creation of sound clinical evidence to support the adoption and long-term utilization of our technology. This includes a balance of high-quality Shockwave-sponsored and investigator-initiated research studies to advance the knowledge of our technology’s performance in daily practice.

Shockwave-sponsored DISRUPT CAD Clinical Program

cad i
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.
cad ii
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.
cad iii
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.
Disrupt CAD IV
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.

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