Genesis MedTech Announces NMPA Approval of Shockwave Intravascular Lithotripsy System for Calcified Coronary and Peripheral Artery Disease
Recently, the National Medical Products Administration (NMPA) released information on approved medical device registration certificates (imported), announcing that Genesis MedTech’s “Shockwave Intravascular Lithotripsy” series has been approved for market launch. This marks the first time the NMPA has approved an intravascular lithotripsy medical device. The certified products from Genesis MedTech include the console system and various models of catheters designed for treating calcified lesions in coronary and peripheral arteries.
In March last year, Genesis Medical and the U.S.-listed company Shockwave Medical established a joint venture controlled by Genesis to introduce the world’s leading new medical technology—intravascular lithotripsy (IVL) for calcification treatment.
According to the plans of both parties, after the product is launched in China, the company will accelerate its localization process: establishing a production line at Genesis’s R&D and manufacturing base in Wuxi for the production of Shockwave intravascular lithotripsy products.
Vascular calcification refers to a pathological condition characterized by the deposition of calcium substances in the vessel wall, leading to vascular stiffening, reduced compliance, and significant therapeutic challenges. With population aging, varying degrees of calcification in both coronary and peripheral arteries have become increasingly prevalent. According to the Chinese Expert Consensus on the Diagnosis and Treatment of Coronary Artery Calcification (2021 Edition), the prevalence of coronary artery calcification increases with age, reaching approximately 50% in individuals aged 40–49 years and about 80% in those aged 60–69 years. Calcification of peripheral arteries is also a common clinical issue.
Calcification in either the coronary or peripheral arteries represents a highly challenging lesion for interventional therapy, particularly severe and deep calcified lesions, which are referred to by interventional physicians as “the hardest bone” or “the most formidable fortress.”
Prior to the approval of Shockwave’s intravascular lithotripsy (IVL) technology, options for managing vascular calcification included rotational atherectomy, directional atherectomy, excimer laser angioplasty, high-pressure balloons, and cutting balloons. However, these modalities have certain limitations. Some involve technically challenging procedures that are complex and time-consuming, even for experienced operators. They also carry a risk of vascular wall injury, potentially leading to an increased incidence of complications. Furthermore, these techniques are generally effective only for superficial intimal calcification, while often proving inadequate for addressing medial calcification and calcified nodules.
Shockwave’s intravascular lithotripsy technology, inspired by extracorporeal shock wave therapy for kidney stones, delivers pulsed acoustic pressure waves to calcified lesions via a balloon catheter. This process “fractures” the calcified plaque, restoring vessel elasticity and blood flow, thereby remodeling diseased vessels while avoiding damage to the vascular intima. Because the shockwave energy acts selectively on hard calcified lesions without harming the normal structure of the vessel wall, it achieves an effect that can be described as “rigid against hardness, compliant against softness, combining strength with flexibility.”
Currently, Shockwave’s products are the only intravascular lithotripsy devices approved for market launch worldwide. The product line includes various catheter models: the catheter designed for treating calcified lesions in peripheral arteries received CE marking in Europe and FDA approval in the United States as early as 2018, and by the end of 2021, it had successfully treated more than 50,000 patients with peripheral artery disease. Meanwhile, the catheter intended for treating calcified coronary lesions obtained CE marking in Europe in 2018 and FDA approval in the United States in 2021; since its commercialization, it has benefited over 70,000 patients with coronary artery disease.
Figure: Schematic diagram of Shockwave’s product acting on blood vessels
Not only has Shockwave’s technology received high clinical acclaim abroad, but it is also widely favored by interventional cardiologists in China. In July 2021, Professor Chen Yundai and his team from the Chinese PLA General Hospital performed the first procedure in China using this technology to treat severely calcified coronary artery lesions. Following the procedure, Professor Chen commented, “Shockwave intravascular lithotripsy is an innovative solution for addressing vascular calcification, particularly deep-seated calcification, and currently represents the only safe and effective treatment modality. Furthermore, due to its ease of operation, intravascular lithotripsy offers significant advantages for widespread adoption.”
Owing to its innovation and safety, the 2021 edition of the Chinese Expert Consensus on the Diagnosis and Treatment of Coronary Artery Calcified Lesions refers to it as the “terminator” of coronary artery calcified lesions.
Figure: Shockwave device and intravascular lithotripsy catheter for coronary arteries
In August of the same year, Professor Fu Weiguo and Professor Dong Zhihui from Zhongshan Hospital, Fudan University, led their team in successfully performing China’s first procedure to treat severely calcified peripheral artery lesions. Professor Fu stated, “The advent of Shockwave has provided a powerful solution for calcified lesions that were previously difficult to manage effectively, making it an indispensable tool for vascular preparation in the future.”
The rapid approval of Shockwave’s intravascular lithotripsy (IVL) products in China not only signifies further recognition of the product’s innovation and clinical value, but also indicates that this cutting-edge technology is poised to benefit patients in China in the near future.