Shockwave Medical, Inc. announced that the Shockwave C2 Coronary IVL Catheter received the regulatory approval in Japan. The approval of Shockwave C2 was supported by noteworthy 30-day results from the Disrupt CAD IV study, a prospective, multicenter study to assess the safety and effectiveness of IVL in 64 Japanese patients that was published last year in Circulation Journal.i The study met the primary safety endpoint (freedom from major adverse cardiac events, or MACE, at 30 days) and effectiveness endpoint (procedural success, defined as residual stenosis <50% by QCA without in-hospital MACE) with rates of 93.8%, which were consistent with results from the Disrupt CAD III study. From a safety perspective, 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%). With the Japan Pharmaceuticals and Medical Devices Agency (PMDA) classifying the Shockwave C2 Coronary IVL Catheter as a new medical device, Shockwave will now await reimbursement approval from the Japanese Ministry of Health, Labour and Welfare (MHLW).