Jiecheng Medical's Transcatheter Aortic Valve System Receives NMPA Approval as Class III Innovative Medical Device in Jiangsu Province

Source: Yangtze Evening News

Recently, the "Transcatheter Aortic Valve System" (Class III) by CAUSPER MEDICAL INC.Innovative HealthcareThe device has passed the review of the National Medical Products Administration (NMPA) and has been approved for marketing.

CAUSPER MEDICAL INC. "Transcatheter Aortic Valve System"

This product is designed for femoral artery access, featuring a movable positioning component that clamps native aortic valve leaflets. Its steerable delivery system accommodates complex anatomical structures such as horizontal hearts. It is suitable for patients who, after assessment by a cardiac team using a scoring system, are diagnosed with symptomatic severe aortic valve regurgitation (severe aortic insufficiency), or combined with aortic stenosis, and are unsuitable for conventional surgical valve replacement. The product is indicated for patients aged 70 years or older. Composed of a transcatheter bioprosthetic valve and a transcatheter delivery system, the product enables valve replacement through minimally invasive interventional techniques without the need for open-heart surgery. This significantly reduces surgical risks and provides a new treatment option for elderly patients or those unable to tolerate traditional surgical procedures.

The Jiangsu Provincial Medical Products Administration (MPA) has been deeply implementing China's national innovation-driven development strategy, continuously advancing the reform of the review and approval system. In close alignment with the National MPA’s deployment to shift the focus of reviews earlier in the process, it addresses the practical challenges posed by the long research and development cycles and high review standards for Class III innovative medical devices. The provincial MPA is committed to optimizing the innovation service environment and refining the pre-review mechanism. With a focus on breakthroughs in core technologies and overcoming "bottleneck" technical challenges, the MPA adheres to a clinical value-oriented approach, strengthening the source innovation of medical devices. Guided by the principle of "early-stage support and full-process acceleration," the MPA promotes the market entry of innovative products through measures such as deepening approval reforms, enhancing technical support, and improving the industrial ecosystem, thereby helping enterprises build new competitive advantages in high-end medical devices.