Sonico-CX IVL System Receives CE Certification, Becoming China's First Dual-Certified Intravascular Lithotripsy Product

(Source: Excel Capital)

Recently, Spectrumedics Medical Technology (Shanghai) Co., Ltd. ("Spectrumedics") announced that its self-developed Sonico-CX Coronary Intravascular Lithotripsy System (IVL) has officially received the EU CE certification. The certification, issued by the globally authoritative body British Standards Institution (BSI), marks the system’s official approval for market entry in the European Union to treat coronary artery calcification.

This move marks another key progress in Spectrumedics' globalization strategy, following the product's approval by the National Medical Products Administration (NMPA) of China and subsequent approvals in multiple markets across Southeast Asia and Latin America.

The Sonico-CX system is designed to safely modify severely calcified plaques through shockwave energy, creating ideal conditions for subsequent stent implantation. The recent CE certification not only demonstrates the product strength of Spectrumedics but will also significantly enhance its brand influence and competitiveness in the international market, laying a solid foundation for further commercial expansion in more regions worldwide.

Dr. Huiqun Peng, Founder and CEO of Spectrumedics, stated: "Receiving the CE certification issued by BSI is a strong testament to our commitment to maintaining world-class quality and innovation. This milestone not only signifies that the Sonico-CX system itself complies with the current EU MDR (EU) 2017/745 regulatory requirements but also demonstrates our company's exceptional capability in compliant quality management systems. With this certification, we are more determined to promote intravascular shockwave technology and treatment solutions globally, allowing more patients with complex calcified lesions to benefit from this innovative technology. Let us jointly advance the development of intravascular shockwave therapy—working together to provide more efficient, safer, and more effective interventional treatments for patients worldwide."

About Spectrumedics

Spectrumedics is an innovative enterprise focusing on high-end cardiovascular interventional devices, dedicated to breaking through key technical barriers and promoting China's original medical technology to go global.

The company's headquarters is located in Shanghai, with a branch office in Singapore serving as the main R&D center and primary window for overseas markets. As a pioneer in China’s intravascular shock wave therapy field, the company’s core product – the intravascular shock wave system – has demonstrated outstanding safety and efficacy in the clinical treatment of complex calcified lesions.

Relying on its self-developed platform, the company has established a complete technical system from material selection, energy transmission, structural design to clinical validation, owning more than 30 patents domestically and internationally, and meeting the conditions for market access in Europe and the United States.

The production and operation base located in Shanghai holds international authoritative certifications such as GMP, ISO 13485, and MDSAP. Relying on a fully compliant quality management system and lean production processes, it ensures the high quality and global compliance of core products, facilitating access to stringent markets such as the United States, the European Union, and Brazil, while continuously enhancing international competitiveness.