SinoStem Portfolio Company Saihe Medical's Coronary IVL System Receives CE MDR Certification, Marking Key Milestone in Global Expansion
SONOSEMI
Active Vascular Implantable and Interventional Medical Device R&D and Manufacturer
Recently,Stoic Capital Investment EnterpriseSonosemi Medical Co., Ltd. (hereinafter referred to as "SONOSEMI"), independently developed Coronary Intravascular Shockwave Treatment System, has officially obtained CE MDR certification.
This important milestone marks a crucial step in SONOSEMI's global strategic layout. As the key pass for entering the EU market, this certification signifies that SONOSEMI has comprehensively reached international standards in product safety, efficacy, and quality management systems. Meanwhile, the stringent regulatory standards and authoritative recognition represented by the CE MDR certification will further enhance SONOSEMI's global brand credibility and industry influence. This milestone breakthrough also demonstrates the competitive potential of China's innovative medical devices in the global high-end market, providing a positive example for Chinese-produced high-end interventional products to "go global."
Currently, the product has been deployed in over 30 countries and regions worldwide. The acquisition of CE certification will also provide strong support for SONOSEMI to accelerate its overseas commercial strategic layout and expand international cooperation opportunities.
SONOSEMI's Coronary Intravascular Shockwave Therapy System consists of the LiqMagic® C14 single-use coronary shockwave catheter and the ISL100 Pro intravascular shockwave therapy device. By providing pulsed driving electrical energy to the shockwave catheter, it can output divergent, low-intensity shockwave energy outwardly in a 360° full circumferential and intermittent manner. This creates a fracturing effect on calcified plaques, improves vascular compliance, and prepares for subsequent treatments while avoiding damage to the intima and normal vascular tissue.
Moreover, the system is easy to operate. With an innovative electrode design, a single shockwave balloon catheter can deliver up to 100 pulses. The balloon comes in seven different specifications, covering sizes from 2.5mm to 4.0mm, making it a standout product in the field of calcified lesion treatment developed and produced in China.
SONOSEMI Chairman Liu BinSaid: "SONOSEMI's First Self-Developed Coronary Shock Wave Treatment System Officially Approved for Market Launch in the EU, Marking International Recognition of SONOSEMI Medical's Independent Innovation Capability and Systematic Development Level in the Field of High-End Interventional Medical Devices. This is not only a significant milestone in the company’s development but also reflects the continuous breakthrough of China’s innovative strength in the global cardiovascular treatment field. SONOSEMI Medical consistently adheres to clinical value as its guiding principle, promoting the deep integration of technological innovation and medical needs. In the future, we will embrace a more open approach to integrate into the global medical innovation ecosystem, collaborate with global partners, and jointly advance precise, powered, and green interventional therapies to benefit a broader patient population.
Sonosemi Medical Co., Ltd. (referred to as "SONOSEMI") was established in April 2020, with its headquarters located in Shenzhen, the forefront of China's technological innovation. As a national high-tech enterprise, it focuses on technological innovation and industrialization in the field of vascular active interventional diagnosis and treatment.
As a provider and pioneer of solutions in this field in China, SONOSEMI always stays at the forefront of the industry and focuses on clinical needs, committed to offering greener, more precise, and safer product solutions. Through a dual-driven model of "clinical demand + technological innovation," the company has pioneered innovative products such as the coronary intravascular shockwave treatment system, intracardiac ultrasound imaging system, and peripheral intravascular shockwave treatment system, gradually building comprehensive solutions for vascular interventional diagnosis and treatment scenarios while striving to create greater value for doctors and patients.
