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] 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 and improving operational convenience [1] - The integrated separation design aims to reduce potential operational risks during the separation process, effectively shortening the device operation time [1] - JensClip's innovative design has been patented globally [1] Group 2: Clinical Trials and Regulatory Progress - One-year clinical follow-up results and challenging case applications of JensClip have been presented at international academic conferences such as EuroPCR, TCT San Francisco, and PCR London Valves, demonstrating excellent safety and efficacy indicators [2] - The product has completed the submission of its registration application to the National Medical Products Administration in China and has received acceptance, currently undergoing the registration review phase [2] - JensClip has successfully commenced clinical applications overseas, and the company is actively promoting the product's registration process to meet widespread clinical needs [2]
健世科技-B(09877.HK)：JensClip已递交CE认证注册申请