Shockwave Medical and Genesis MedTech obtain regulatory approval in China for intravascular lithotripsy

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Shockwave Medical and Genesis MedTech Group announced today that they have successfully obtained approval from China’s National Medical Products Administration (NMPA) to market and sell the Shockwave intravascular lithotripsy (IVL) system with the Shockwave C2 coronary IVL catheters and the Shockwave M5 and S4 peripheral IVL catheters in China.

A joint venture between Genesis MedTech and Shockwave was formed in March of 2021 as a partnership to distribute Shockwave’s products in China and to leverage Genesis MedTech’s Wuxi research and development and production base to accelerate the manufacturing of Shockwave’s products for the local Chinese market.

The Shockwave M5 and S4 IVL catheters, which are used for the treatment of peripheral arterial calcification lesions, are approved in the USA, the European Union, and other select international jurisdictions and have been used to help treat more than 50,000 patients globally who suffer from peripheral arterial disease (PAD). The Shockwave C2 coronary IVL catheters, which are used for the treatment of coronary arterial calcification lesions, are approved in the USA, the European Union, and other select international jurisdictions, and have been used to help treat more than 70,000 patients globally who suffer from coronary artery disease.

In July 2021, Yundai Chen of the Chinese People’s Liberation Army General Hospital (Beijing, China) led a team to perform the first clinical IVL procedure in China to treat a patient with severely calcified coronary artery lesions. “Shockwave IVL technology is an innovative solution for treating coronary artery calcification, especially when the calcium is deep in the artery. The technology is easy to use, which is good for increasing access,” commented Chen.

In August of 2021, Weiguo Fu and Zhihui Dong, both of Zhongshan Hospital (affiliated to Fudan University, Shanghai, China) led their team to successfully complete the first clinical IVL procedure in China on severely calcified lesions in peripheral arteries. Fu said: “Shockwave IVL provides a powerful solution to calcified lesions that could not be effectively treated in the past. It is a promising and indispensable approach for the future.”

With an ageing population, there is an increasing incidence of calcified vascular disease in China. According to the Chinese Expert Consensus on the Diagnosis and Treatment of Calcific Coronary Lesions 2021 (Expert Consensus Statement 2021), the risk of developing coronary artery calcification increases with age, with an incidence rate of about 50% in people aged 40–49 years and about 80% in people aged 60–69 years. Calcification is also a common problem in patients with PAD. According to Statistica, China had a population of over 1.4 billion in 2020, 50% of whom were over the age of 40.

“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,” said Doug Godshall, chief executive officer of Shockwave Medical. “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.


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