Shockwave Medical’s C² Coronary IVL Catheter Approved in Japan

March 30, 2022—Shockwave Medical, Inc., a developer of intravascular lithotripsy (IVL) to treat severely calcified cardiovascular disease, announced that the Shockwave C² coronary IVL catheter received regulatory approval from the Pharmaceuticals and Medical Devices Agency in Japan. The company awaits reimbursement approval from the Japanese Ministry of Health, Labor, and Welfare.

The Shockwave C² coronary IVL catheter received European CE Mark approval in 2018. In the United States, the device was approved by the FDA in 2021.

The approval of the Shockwave C² device in Japan was supported by 30-day results from the prospective multicenter DISRUPT CAD IV study that assessed the safety and effectiveness of IVL in 64 Japanese patients.

Shigeru Saito, MD, et al published these findings in Circulation Journal, the official journal of the Japanese Circulation Society (2021;85:826-833). Shockwave announced the initiation of DISRUPT CAD IV in November 2019.

According to the company, the study met the primary safety endpoint of freedom from major adverse cardiac events (MACE) at 30 days and the effectiveness endpoint of procedural success (defined as residual stenosis < 50% by quantitative coronary angiography without in-hospital MACE) with rates of 93.8%. These findings were consistent with results from the DISRUPT CAD III study, which the company announced in October 2020.

In terms of safety, there were no perforations, abrupt closures, or slow/no-reflow events at any time during the procedures. With all patients receiving intravascular imaging, final stent outcomes showed excellent minimum stent area (5.7 mm²) and stent expansion at the site of maximum calcification (99.5%).

Dr. Saito, MD, who serves as Principal Investigator of DISRUPT CAD IV, is Director of the Department of Cardiology and Catheterization Laboratory at the Shonan Kamakura General Hospital in Kamakura, Japan.

“Coronary IVL has clearly demonstrated the ability to safely and effectively treat severely calcified coronary lesions in a Japanese population,” commented Dr. Saito in Shockwave’s press release. “Given the safety profile shown to date across multiple studies and calcium morphologies, along with its ease of use, I am confident that coronary IVL will offer Japanese physicians a truly unique treatment option for our most challenging patients with calcified lesions.”