Shockwave coronary IVL gains Japanese approval 30th March 2022
Shockwave Medical’s C2 coronary intravascular lithotripsy (IVL) catheter has received regulatory approval in Japan.
“Coronary IVL has clearly demonstrated the ability to safely and effectively treat severely calcified coronary lesions in a Japanese population,” said Shigeru Saito (Shonan Kamakura General Hospital, Kamakura, Japan) and principal investigator of Disrupt CAD IV, one of the studies used to support approval for Shockwave C2 in Japan.
“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,” adds Saito.
The approval of Shockwave C2 was supported by 30-day results from the Disrupt CAD IV study, a prospective, multicentre study to assess the safety and effectiveness of IVL in 64 Japanese patients that was published last year in Circulation.
The study met the primary safety endpoint, freedom from major adverse cardiac events (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%).
“We are delighted to be partnering with the Japanese Association of Cardiovascular Intervention and Therapeutics (CVIT) to make this therapy available to the expert cardiologists in Japan,” said Doug Godshall, Chief Executive Officer of Shockwave Medical. “With Japan’s worldwide leadership in the adoption of intravascular imaging and systematic approach to optimising lesion preparation, we are confident that CVIT will be the perfect partner to help ensure that coronary IVL will play a vital role in the future calcium treatment algorithms of Japanese physicians.”
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).
The Shockwave C2 Coronary IVL Catheter previously received CE mark in 2018 and premarket approval from the US Food and Drug Administration (FDA) in 2021.