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健世科技-B(09877):JensClip已递交CE认证注册申请
智通财经网· 2025-12-28 23:48
Core Viewpoint - The company has submitted a CE certification application for its innovative transcatheter mitral valve repair system, JensClip, marking a significant step in its internationalization strategy [1][2] Group 1: Product Overview - JensClip is designed for the treatment of severe mitral regurgitation, featuring a user-friendly and reliable operation [1] - The device includes a claw-wedge mechanical locking design that allows for locking at any angle, ensuring stable and reliable coaptation of the leaflets [1] - The diamond-shaped valve clip design facilitates retrieval and repositioning, enhancing safety during the procedure [1] - The integrated separation design aims to reduce potential operational risks during the separation process, effectively shortening the operational time [1] Group 2: Clinical and Regulatory Progress - The one-year clinical follow-up results and challenging case applications of JensClip have been presented at major international conferences, demonstrating excellent safety and efficacy indicators [1] - In China, the product has completed the submission of its registration application to the National Medical Products Administration and is currently under review [2] - JensClip has successfully commenced clinical applications overseas, with the company actively promoting the registration process to meet broad clinical needs [2]