SHE Medical's Coronary Intravascular Lithotripsy System Becomes China's First Domestically Developed IVL Therapy Approved by NMPA

Oct 30, 2023 18:15 CST Updated 18:15

SONOSEMI

Active Vascular Implantable and Interventional Medical Device R&D and Manufacturer

Instrument Family

Medical Device Media Reporting Pioneer

Share Professional Medical Device Knowledge

Source: Arterial Network

Recently, the Coronary Intravascular Shockwave 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 release, becomingChina'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 types of 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 treatment techniques and tools have certain limitations. Intravascular lithotripsy technology innovatively combines the hydroelectric effect with balloon angioplasty to create a new approach.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. The technology is easy to operate, has excellent safety, and is referred to as the "terminator" of calcified lesions in the "Chinese Expert Consensus on Diagnosis and Treatment of Coronary Artery Calcified Lesions."

SONOSEMI's independently developedThe Coronary Intravascular Shockwave Treatment System consists of the LiqMagic® C14 Single-Use Coronary Intravascular Shockwave Catheter (NMPA Approval No. 20233011546).Composed of the ISL100 Pro Intravascular Shockwave Therapy Device (China Medical Device Registration No. 20233011545). The device delivers 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 intima and normal vascular tissue. To meet the increasing 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 complete 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 development journey of SONOSEMI. 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 stay true to its original mission and continue to focus on technological innovation in cardiovascular interventional devices, empowering clinical diagnosis and treatment scenarios."

References

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

2. J Am Coll Cardiol. 2014;63(18):1845-1854.

3. Interv Cardiol. 2019;14(3):154-163.

END