Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has given approval to Shockwave Medical’s Shockwave C² Coronary Intravascular Lithotripsy (IVL) Catheter.
The regulatory approval was supported by 30-day results obtained from the prospective, multicentre Disrupt CAD IV study.
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In the study, the Shockwave C² Coronary IVL Catheter’s safety and effectiveness were evaluated in 64 Japanese patients.
Shockwave Medical noted that the device met the primary safety endpoint – freedom from major adverse cardiac events (MACE) at 30 days. It also met the effectiveness endpoint with a rate of 93.8%.
The findings from the study were consistent with the data obtained from the Disrupt CAD III trial.
In terms of the safety aspect of the device, there were no abrupt closures, perforations or slow/no-reflow events noted at any time during the procedures.
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By GlobalDataAll participants of the Disrupt CAD IV study received intravascular imaging, which revealed final stent outcomes of a minimum stent area of 5.7mm² and stent expansion at the maximum calcification site of 99.5%.
Shockwave Medical CEO Doug Godshall said: “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.
“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.”
Last year, the Shockwave C² coronary IVL catheter received premarket approval (PMA) from the US Food and Drug Administration (FDA). It also received CE Mark in 2018.
Currently, the company is awaiting reimbursement approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for the device.
