U.S. Pivotal Study for Coronary IVL

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

Caution: Investigational Device. Limited by Federal (or United States) law to investigational use.