Qiming Medical-B (02500): CardioValve transcatheter tricuspid valve replacement system submits CE MDR certification application

Zhitongcaijing · 1d ago

Zhitong Finance App News, Qiming Medical-B (02500) issued an announcement. Recently, the Group has officially submitted all application materials for CE MDR certification for the Cardiovalve Transcatheter Tricuspid Valve Replacement System (Cardiovalve System) to the European Notified Body.

The Cardiovalve system is a transcatheter interventional replacement product that can be used to treat both mitral valve reflux and tricuspid valve reflux. Compared with similar products, the Cardiovalve system's access method through the femoral vein significantly improves treatment safety. The maximum 55mm large valve ring design of the product is suitable for about 95% of patients. At the same time, its unique short valve holder design can effectively reduce the risk of ventricular outflow obstruction. The Cardiovalve system is easy to operate, safe, and highly replicable. It only requires three steps: positioning, anchoring, and release.