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Japan Approves Shockwave's Intravascular Lithotripsy for Coronary Interventions
Safe, Effective Method for Treating Severely Calcified Coronary Lesions
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Shockwave Medical’s Intravascular Lithotripsy System |
April 2, 2022 -- Previously approved in the European and U.S. markets, Shockwave Medical's Intravascular Lithotripsy (#IVL) system for treating severely calcified coronary lesions has now been approved by the Japanese regulatory agency.
A major problem in placing stents to open blocked coronary arteries is the presence of a calcium "collar" around the blockage which prevents the full expansion of the stent. Previously methods to alleviate this include a cutting balloon or rotational atherectomy with a high speed burr, such as the Boston Scientific's RotaBlator.
But several studies and registries have shown that ultrasound disruption of the calcium surrounding these lesions is both safe and effective. The procedure is fast, easy, with a very short learning curve.
Dr. Shigeru Saito |
Dr. Shigeru Saito stated in the company's press release: "Coronary IVL has clearly demonstrated the ability to safely and effectively treat severely calcified coronary lesions in a Japanese population.
"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.”
Satoru Hashimoto
TCROSS News |
The implications for the Japanese patient population are significant. As Satoru Hashimoto, Founder and CEO of TCROSS News, Angioplasty.Org's Japanese partner, wrote us in an email, "Dr. Shigeru Saito recently presented the latest outcome, one-year safety and efficacy, at the 86th Annual Meeting of the Japanese Circulatory Society (JCS) held between March 11th and 13th as reported at TCROSS NEWS GLOBAL (https://www.tcross.co.jp/english/japan/3928) on March 13th . The Kaplan-Meier analysis showed the MACE rate of 6.3% at 30 days and 9.4% at 1-year. He also reported no cardiac death at 1-year follow-up. As we all know, severe calcification affects poor prognosis for patients who undergo coronary intervention and it is commonly observed for patients with diabetes mellitus and or who are undergoing hemodialysis. Many such patients exist In Japan; thus, the availability of Shockwave C2 Coronary IVL Catheter may affect the current clinical practice and certainly improve both acute and long-term outcome for those who have severe calcification."
The press release from Shockwave Medical Inc. follows:
Shockwave Medical Announces Japanese Regulatory Approval of Coronary IVL
Transformative Shockwave C2 Intravascular Lithotripsy Catheter Will Soon Be Available in One of the World’s Largest Coronary Intervention Markets
March 30, 2022 -- Santa Clara, California, USA -- Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the development of Intravascular Lithotripsy (IVL) to treat severely calcified cardiovascular disease, announced today that the Shockwave C2 Coronary IVL Catheter received the regulatory approval in Japan.
Dr. Shigeru Saito |
Coronary IVL has clearly demonstrated the ability to safely and effectively treat severely calcified coronary lesions in a Japanese population,” said Shigeru Saito, MD, FACC, FSCAI, FJCC, 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.”
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. 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 percent, 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).
Doug Godshall
CEO, Shockwave Medical |
“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 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 (FDA) in 2021.
About Shockwave Medical, Inc.
Shockwave Medical is focused on developing and commercializing products intended to transform the way calcified cardiovascular disease is treated. 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. To view an animation of the IVL procedure and for more information, visit www.shockwavemedical.com.
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Reported by Burt Cohen, April 2, 2022
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