Shenqi Medical Secures CE MDR Certification for Left Atrial Appendage Occluder System, Detachable Fibered Coil Embolization System, and Peripheral Microcatheter

Feb 08, 2025 08:04 CST Updated 08:04

Shenqi Medical

Cardiovascular Interventional Device Developer

China, Shanghai - Recently,Shanghai Shenqi Medical Technology Co., Ltd.(hereinafter referred to as "Shenqi Medical") independently developedLeft Atrial Appendage Occluder System，Detachable Fibered Coil Embolization System and Peripheral MicrocatheterObtained EU CE MDR certification.

This is the first CE certification obtained by Shenqi Medical, achieving the registration of Shenqi Medical products in EU countries and filling the gap in the EU market.

Shenqi Medical Multi-line Products ObtainThe First EU CE MDR Certificate Produced in China

Left Atrial Appendage Occluder SystemComposed of a left atrial appendage occluder and a delivery system, the left atrial appendage occluder is released into the left atrial appendage through the delivery system during clinical use to prevent strokes caused by thrombus detachment within the left atrial appendage. The traditional treatment for thrombosis in atrial fibrillation patients involves long-term use of anticoagulant drugs. However, long-term use of such drugs is expensive and carries severe side effects, such as gastrointestinal bleeding and cerebrovascular bleeding. LAAC technology (percutaneous left atrial appendage closure) is an innovative alternative to long-term anticoagulant drug therapy. With continuous advancements in modern radiological imaging diagnostic technologies, minimally invasive cardiac interventional treatments have rapidly developed, allowing LAAC technology to be continuously refined. Patient demand (number of procedures) has been increasing rapidly year by year. Shenqi Medical's left atrial appendage occluder system was independently researched, developed, and designed based on summarizing the advantages, disadvantages, and clinical performance of similar products, with the company holding full independent intellectual property rights.This product has obtained the first CE MDR certificate for domestically produced similar products in China.Proven to meet European advanced standards.

Qi Yi^®Detachable Fiber-Coated Coil Embolization SystemIt is a domestically produced medical device developed by Shenqi Medical for minimally invasive interventional treatment of peripheral arterial embolism. The system can effectively embolize hemangiomas and aneurysms, achieving the purpose of treatment.As the first domestically produced, dedicated peripheral vascular detachable fiber-coated coil embolization system to be marketed in China,The acquisition of the CE certificate has provided the prerequisite for this product to enter the international market and will further enhance its competitiveness in the global market.

Peripheral MicrocatheterMainly used for injecting diagnostic, embolic, or therapeutic substances through human peripheral blood vessels. Can be used in conjunction with coils to transport the coils to the affected area. This product, combined with the Qi Yi® Detachable Fibered Coil Embolization System, provides an integrated solution for peripheral vascular diseases, making the operation more convenient and flexible for doctors during coil embolization procedures.

AboutShenqi Medical

As a medical enterprise rooted in China, Shenqi Medical adheres to the concept of "Innovation·Cardioprotection" and always takes "better meeting the rapidly growing healthcare needs of the Chinese market" as its mission. By developing innovative and high-quality cardiac and vascular interventional products, it provides comprehensive solutions in the field of cardiovascular disease treatment, benefiting more patients in China. In the future, Shenqi Medical will position and innovate its products for the global market, actively participate in global competition in related fields, and is committed to launching more high-quality and advanced medical device products, providing more comprehensive disease treatment solutions for patients both domestically and internationally.