The high rate of procedural success, combined with the low rate of major adverse cardiovascular events in CAD III, not only met the performance goals, but it also surpassed our expectations as investigators." In the United States, Shockwave's C2 coronary IVL catheters are limited to investigational use. The company stated that DISRUPT CAD III was based on a predicate study—the pivotal single-arm ORBIT II IDE study of Cardiovascular Systems, Inc.'s Diamondback 360 coronary orbital atherectomy system—to develop performance goals that would allow the FDA to evaluate the safety and effectiveness of IVL in a single-arm study. The devices are commercially available for the treatment of de novo coronary artery disease in Europe and select other geographies.