JENSCARE-B(09877): JensClip has submitted an application for CE certification registration.
Jianshi Technology-B (09877) announced that recently, the company's transcatheter mitral valve repair (TMVr) system JensClip has officially submitted an application for CE certification registration. This is another successful product after the company's transcatheter tricuspid valve replacement system LuX-Valve Plus to submit an application for CE certification registration, marking an important milestone in the company's internationalization strategy.
JENSCARE-B (09877) Announcement: Recently, the company has officially submitted the CE certification registration application for the transcatheter mitral valve repair (TMVr) system JensClip. This is another successful submission of a CE certification registration application by the company following the transcatheter tricuspid valve replacement system LuX-Valve Plus, marking an important step in the company's internationalization strategy.
JensClip is an Innovative Medical Management device designed to treat severe mitral valve regurgitation. The device is easy and reliable to operate. Its claw-wedge mechanical locking design allows locking at any angle, ensuring stable and reliable leaflet coaptation, and is expected to effectively improve mitral valve regurgitation and reduce leaflet tension. Its diamond-shaped valve clamp design is easy to retrieve and reposition, making cross-leaflet operation safer and more efficient. Its integrated detachment design is expected to reduce the potential risks of misoperation during detachment and effectively shorten the operation time of the device. The innovative design of JensClip has been patented globally.
The 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 in 2025, garnering widespread attention due to its excellent safety and efficacy indicators.
Currently, JensClip has completed the registration application submission and acceptance by the China National Medical Products Administration. The one-year follow-up results have been excellent and the product is now in the registration evaluation stage. JensClip has also been successfully used in clinical applications overseas. The company will actively promote the registration process of this product to meet a wide range of clinical needs.
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