Shenzhen Saihe Medical's Intravascular Lithotripsy System for Coronary Arteries Receives NMPA Approval

Recently, the Coronary Intravascular Shock Wave Treatment System independently developed by Sonosemi Medical Co., Ltd. (hereinafter referred to as "SONOSEMI") has officially received approval from the National Medical Products Administration (NMPA) for market launch, becoming...China's first domestically produced coronary shock wave treatment system to be approved.

The incidence of coronary artery calcification is high. Epidemiological data shows that coronary artery calcification increases with age, with an incidence of about 50% in the 40-49 age group and approximately 80% in the 60-69 age group. The ACUITY and HORIZONS-AMI studies indicate that the incidence of moderate to severe calcified lesions exceeds 30%. Coronary calcification represents one of the most challenging lesions in percutaneous coronary intervention (PCI), often referred to as "the hardest bone to crack." For such lesions, the success rate of device treatment is low, the incidence of intraoperative complications is high, and patients experience poor long-term outcomes. Both calcification management techniques and tools have certain limitations. Intravascular lithotripsy technology innovatively combines the hydraulic effect with balloon angioplasty to form a novel solution.Vascular Calcification Plaque Treatment Technology, it is not only effective for superficial calcification but also the only currently available treatment technology that effectively addresses deep calcification. This technique is easy to operate, offers excellent safety, and has been hailed as the "terminator" of calcified lesions by the "Chinese Expert Consensus on Diagnosis and Treatment of Coronary Artery Calcification."

SONOSEMI's independently developedThe Coronary Artery Intravascular Shockwave Treatment System by LiqMagic^®C14 Disposable Coronary Intravascular Shockwave Catheter (China Medical Device Registration No. 20233011546) and ISL100 Pro Intravascular Shockwave Treatment Device (China Medical Device Registration No. 20233011545)Composition. The device provides pulsed driving electrical energy to its shockwave catheter, enabling it to output divergent, low-intensity shockwave energy in a 360° full circumferential and intermittent manner. This exerts a crushing effect on calcified plaques, improves vascular compliance, and prepares for subsequent treatments while avoiding damage to the lumen intima and normal vascular tissue. To meet the growing clinical demand for precision treatment and application scenarios,LiqMagic^®C14 Disposable Coronary Intravascular Shockwave Catheter Offers More Pulses(100 times),Higher Pressure Resistance(RBP reached 14atm) andA more comprehensive range of specifications and models(2.5-4.0mm, 7 specifications in total).

Mr. Liu Bin, Chairman of SONOSEMI, stated: "We are very pleased to see the official approval of SONOSEMI's first product, which is another significant milestone in the company’s development journey. We believe this innovative breakthrough technology, with its excellent safety, efficacy, and convenience, will provide strong support for a wider range of clinicians and patients. As a China-based medical innovation enterprise, SONOSEMI will remain true to its original mission and continue to focus on technological innovation in cardiovascular interventional devices, empowering clinical diagnosis and treatment scenarios."

SONOSEMI, founded in April 2020 and headquartered in Shenzhen, is a high-tech enterprise dedicated to the research, development, manufacturing, and sales of active vascular implantable and interventional medical devices. The company leverages core technologies such as ultrasound and medical sensors to drive continuous technological innovation in active vascular diagnostic and therapeutic devices. Through a cross-regional dealer network and service support platform, SONOSEMI is committed to providing high-quality products and services to healthcare providers and patients, continuously creating value for them and empowering smart healthcare.

References

Chinese Journal of Interventional Cardiology, 2021;29(5):251-259.

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