March 30, 2022: Shockwave Medical has announced that it has received approval in Japan for the Shockwave C2 intravascular lithotripsy (IVL) catheter for the treatment of highly calcified lesions in coronary arteries.
Shockwave Medical Receives Approval for Coronary IVL Catheter in Japan
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The approval is based on the Japanese multicenter Disrupt CAD IV study, in which 64 patients treated with IVL for de novo highly calcified lesions in coronary arteries showed positive results in the primary safety endpoint (freedom from MACE at 30 days) and primary effective endpoint (procedural success rate).
At the 86th Annual Meeting of the Japanese Circulation Society, Dr. Shigeru Saito of Shonan Kamakura General Hospital reported the 1-year results, and the Kaplan-Meier analysis showed a MACE (cardiac death, MI, TVR) rate of 9.4% at 1-year. There were zero cardiac deaths in this study, four non-Q-wave MI during hospitalization but zero (6.3%) after discharge, and a TVR rate of 4.7%. The 1-year rates of TLF (cardiac death, MI related to the target vessel, and TLR of ischemic origin) were 6.3%, the MI related to the target vessel was 6.3%, the TLR of ischemic origin was in only one case (1.6%), and definite/probable stent thrombosis was zero.
※コンテンツには、国内で未承認、適応外の医療機器、医薬品、または効能・効果/用法・用量の情報を含む場合がありますが、未承認、適応外の使用を推奨するものではありません。
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