Ningbo-based structural heart disease device manufacturer Jenscare Scientific Co., Ltd (HKG: 9877) has announced that its transcatheter tricuspid valve replacement system, LuX-Valve, did not pass the approval review by China’s Center for Medical Device Evaluation (CDME).
The LuX-Valve, which was granted innovative medical device status in China in 2019 and qualified for a special review channel, had its marketing application filed in Q4 2022, supported by one-year follow-up data. Despite this setback, Jenscare remains confident in the clinical benefits and commercial prospects of LuX-Valve and is committed to evaluating the impact of the regulatory decision and continuing to pursue global commercialization efforts for the LuX-Valve series.- Flcube.com
