Major Milestone: Spectrum Medical's Coronary Intravascular Lithotripsy System Receives NMPA Approval

Recently, the coronary intravascular shock wave treatment system independently developed by Spectrumedics Medical Technology (Shanghai) Co., Ltd. ("Spectrumedics") has been officially approved for marketing by the National Medical Products Administration (NMPA).

This is currently the only domestically produced and self-developed coronary intravascular shockwave treatment product in China to have received an authorized invention patent, successfully breaking through technological bottlenecks of similar foreign products.

The prevalence and number of patients with coronary artery disease continue to increase. Epidemiological data from the "Chinese Expert Consensus on the Diagnosis and Treatment of Coronary Artery Calcification" shows that coronary artery calcification increases with age, with an incidence rate of 50% in the 40 to 49 age group and 80% in the 60 to 69 age group. Among patients undergoing percutaneous coronary intervention (PCI), the proportion of moderate to severe calcified lesions can reach 30.8%. Coronary calcification represents a particularly challenging lesion in percutaneous coronary intervention (PCI). Traditional calcification treatment techniques and devices still have certain limitations when used to manage coronary calcified lesions. The incidence of intraoperative complications is high, and long-term patient outcomes are poor.

Intravascular Shockwave Technology applies acoustic pressure waves to calcified areas, and the balloon catheter can effectively loosen or crack calcified lesions, restoring vascular elasticity. This technology is not only effective for superficial circumferential and eccentric calcifications but is also currently the only technique effective for deep calcifications.This technology is easy to operate, has good safety, and is called a new choice and powerful "weapon" for coronary artery calcification lesions in the "Chinese Expert Consensus on Diagnosis and Treatment of Coronary Artery Calcification Lesions", and is expected to become the "terminator" of coronary artery calcification lesions.

After the shockwave balloon product obtains marketing approval, the company will continue its innovative research and development, expand the indications of the shockwave platform, and continuously provide clinical doctors with more effective and innovative solutions for treating cardiovascular diseases. At the same time, it will promote cost-effective locally produced innovative products from China to overseas markets.