Domestic Medical Devices Gain New Innovative Milestone: 432nd Breakthrough Product Approved

　　【Pharmaceutical Network | Industry Trends] On June 24, 2026, the registration application for the "Transcatheter Aortic Valve System" developed by Shanghai Hanling Medical Device Co., Ltd. was approved by the National Medical Products Administration. With the approval of this product, a total of 432 innovative medical devices have been approved for market launch in China to date.
 

The transcatheter aortic valve system approved in this instance consists of an aortic valve, a delivery system, a vascular sheath kit, and a crimping device. It is indicated for patients with symptomatic severe aortic regurgitation (severe aortic insufficiency) who are deemed unsuitable for conventionalSurgeryPatients undergoing valve replacement and aged ≥70 years.
 

Amid the accelerating aging of the population, the incidence of valvular heart disease continues to rise, with severe aortic regurgitation becoming a common cardiovascular condition threatening the health and lives of the elderly. This product integrates sinus-bottom anchoring, leaflet clamping, and steerable precise delivery into a unified system, forming a dedicated balloon-expandable valve solution for patients with aortic regurgitation. It is expected to improve implantation success rates while reducing the risks of valve migration, paravalvular leak, and permanent pacemaker implantation.
 

The launch of this innovative product is underpinned by the company’s sustained, in-house R&D expertise accumulated through its deep engagement in the structural heart disease sector. According to available information, Shanghai Hanling Medical Devices is a subsidiary of Shanghai Yingtai Medical Devices Co., Ltd. The company focuses on the research and development of innovative devices in the field of structural heart disease, continuously strengthening its independent innovation capabilities to develop products with proprietary intellectual property rights.
 

From the perspective of industry development, the approval and market launch of this product epitomize the continuous empowerment of China’s medical device innovation policies and the steady enhancement of R&D capabilities among domestic enterprises. To date, 432 innovative medical devices have been approved for marketing in China, marking ongoing breakthroughs for domestically produced medical devices. According to available data, nine innovative medical devices alone were approved in June this year.
 

On June 18, the registration applications for ForQaly Medical (Shanghai) Co., Ltd.’s interventional left ventricular assist device and interventional left ventricular assist catheter pump kit were approved. These two products are used in combination to provide left ventricular support for adult patients with severe coronary artery disease, reduced left ventricular ejection fraction, and stable hemodynamics undergoing high-risk percutaneous coronary intervention (PCI). The product features an extracorporeal motor design connected via a flexible drive shaft, enabling blood pumping from the left ventricle into the aorta for short-term left ventricular assistance.
 

Shanghai Jinkui Medical Device Co., Ltd.’s innovative product, the “Self-Expanding Single-Rivet Bioresorbable Atrial Septal Defect Occluder,” was approved on June 8. This bioresorbable occluder for atrial septal defects features self-expanding and shape-recovery properties. It consists of a mesh body, connector, separator membrane, and sutures, and is used for transcatheter minimally invasive interventional closure of atrial septal defects. The product is easy to operate in clinical practice, is expected to reduce mechanical injury to septal tissue, thereby lowering the incidence of arrhythmias and enhancing implantation safety for patients...
 

Standing at a new starting point for industrial development, Shanghai Hanling Medical Devices will leverage the approval of its latest product as an opportunity to deepen its commitment to the field of structural heart disease treatment. The company will focus on addressing unmet clinical needs through iterative product upgrades and the development of new technologies, continuously enriching its pipeline. By capitalizing on the full-industry-chain advantages of its parent company, Shanghai Hanling aims to accelerate the clinical promotion and market adoption of innovative medical devices. Looking ahead, as more domestic medical device companies remain dedicated to independent innovation and persist in overcoming core technological challenges, the pace of import substitution for high-end medical devices in China will continue to accelerate, thereby strengthening the technical foundation for the nation's healthcare sector.
 

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