Shockwave Medical and Genesis MedTech Gain Chinese Regulatory Approval for Coronary and Peripheral Intravascular Lithotripsy Platforms

May 23, 2022—Shockwave Medical and Genesis MedTech jointly announced regulatory approval of the Shockwave C² Coronary IVL (intravascular lithotripsy) catheters and the Shockwave M⁵ and S⁴ Peripheral IVL catheters by China’s National Medical Products Administration (NMPA).

The Shockwave C2 Coronary and the M⁵ and S⁴ platforms are used in coronary and peripheral arterial calcification lesions, respectively. They have previously been approved in the United States, the European Union, and other markets.

The companies note that the first clinical coronary IVL procedure in China was performed by Prof. Yundai Chen and colleagues at the Chinese People’s Liberation Army General Hospital in July 2021, and the first peripheral procedure was performed by the team of Prof. Weiguo Fu and Prof. Zhihui Dong of ZhongShan Hospital in August 2021.

“Approval in China represents another milestone in the international expansion for Shockwave’s IVL technology. We are very appreciative of the work and the quick regulatory approval by the NMPA—despite the difficult conditions in China in the past months—and its recognition of IVL’s clinical value for patients in China,” commented Shockwave Medical CEO Doug Godshall in the companies’ announcement. “Genesis MedTech is a perfect partner for Shockwave in China, and this accomplishment underscores the value of their established infrastructure and local relationships. We look forward to our continued relationship as we bring IVL to physicians and patients in China for treatment of arterial calcification.”

The companies partnered on the distribution of Shockwave products in the Chinese market in March 2021.