Core Viewpoint - The company has submitted a CE certification application for its transcatheter mitral valve repair system, JensClip, marking a significant step in its internationalization strategy [1][2] Group 1: Product Development - JensClip is designed for the treatment of severe mitral regurgitation, featuring a user-friendly and reliable operation [1] - The device incorporates 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 detachment design aims to reduce potential operational risks during the detachment 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 academic conferences, demonstrating excellent safety and efficacy indicators [1] - The product has completed the registration application submission to the National Medical Products Administration in China 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]
健世科技-B：JensClip已递交CE认证注册申请