Shockwave Gets a Little Pep in Its Step with Breakthrough Device Designation

The regulatory pathway for Shockwave Medical’s Intravascular Lithotripsy (IVL) technology just received a huge jolt from FDA. The agency granted the Santa Clara, CA-based company breakthrough device designation for the Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter. The firm’s device is designed to fracture problematic calcium using sonic pressure to facilitate stent delivery, deployment, and optimal expansion, thereby improving blood flow to the heart muscle. Shockwave’s technology is being evaluated in the DISRUPT CAD III, a prospective, non-randomized, multicenter global IDE study. The company said the study is approved to enroll 442 patients at 50 centers in the U.S. and Europe, and is led by co-principal investigators Drs. Dean Kereiakes and Jonathan Hill. Shockwave Medical’s CEO Doug Godshall told MD+DI, “We remain on track to complete enrollment in the second quarter of 2020 and are a bit ahead of plan. In our most recent earnings call for Q2 we gave the update that investigators have enrolled 108 patients as of the end of June.” Godshall said there was a pretty significant market for the technology. “Due to the increasing prevalence of calcified cardiovascular disease, the market growth for plaque modification devices exceeds that of PCI procedure growth,” Godshall said. “We believe the safe...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Cardiovascular Source Type: news