Michael Barbella, Managing Editor05.16.22
Shockwave Medical Inc. has received regulatory approval in Japan for the Shockwave C2 Coronary IVL Catheter.
“Coronary IVL has clearly demonstrated the ability to safely and effectively treat severely calcified coronary lesions in a Japanese population,” said Shigeru Saito, M.D., director of the Department of Cardiology and Catheterization Laboratory at the Shonan Kamakura General Hospital in 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.”
Shockwave C2's approval was supported by 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 percent by QCA without in-hospital MACE) with 93.8 percent rates, 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 percent).
“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, CEO of Shockwave Medical. “With Japan’s worldwide leadership in the adoption of intravascular imaging and systematic approach to optimizing 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 PMA approval from the U.S. Food and Drug Administration in 2021.
Shockwave Medical develops and commercializes products to treat calcified cardiovascular disease. The company aims to establish a new standard of care for the interventional treatment of atherosclerotic cardiovascular disease through differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque, which the company refers to as Intravascular Lithotripsy (IVL). IVL is a minimally invasive, easy-to-use and safe way to significantly improve patient outcomes.
Reference
i https://doi.org/10.1253/circj.CJ-20-1174
“Coronary IVL has clearly demonstrated the ability to safely and effectively treat severely calcified coronary lesions in a Japanese population,” said Shigeru Saito, M.D., director of the Department of Cardiology and Catheterization Laboratory at the Shonan Kamakura General Hospital in 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.”
Shockwave C2's approval was supported by 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 percent by QCA without in-hospital MACE) with 93.8 percent rates, 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 percent).
“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, CEO of Shockwave Medical. “With Japan’s worldwide leadership in the adoption of intravascular imaging and systematic approach to optimizing 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 PMA approval from the U.S. Food and Drug Administration in 2021.
Shockwave Medical develops and commercializes products to treat calcified cardiovascular disease. The company aims to establish a new standard of care for the interventional treatment of atherosclerotic cardiovascular disease through differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque, which the company refers to as Intravascular Lithotripsy (IVL). IVL is a minimally invasive, easy-to-use and safe way to significantly improve patient outcomes.
Reference
i https://doi.org/10.1253/circj.CJ-20-1174
