News Release Details
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
“Coronary IVL has clearly demonstrated the ability to safely and effectively treat severely calcified coronary lesions in a Japanese population,” said
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
“We are delighted to be partnering with the
The Shockwave C2 Coronary IVL Catheter previously received CE Mark in 2018 and PMA Approval from the
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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Source: Shockwave Medical, Inc.