Jenscare Scientific Co., Ltd. announced that the transcatheter tricuspid valve replacement system products independently developed by the Company have been enrolled in the Total Product Life Cycle Advisory Program pilot of the U.S. Food and Drug Administration. TAP aims to ensure that patients in the U.S. can take the lead globally in accessing high-quality, safe, effective and innovative medical devices in the next few years by promoting early, frequent and strategic communication between the FDA and medical device manufacturers. As of September 8, 2023, the FDA has included 9 devices in the TAP pilot.

The FDA will provide diversified strategic assistance for the devices enrolled, which are of great significance to public health, including more timely pre-market communication and improving the efficiency of the pre-market review process. It is expected that this will effectively accelerate the clinical trials and commercialization progress of the TTVR Products in the U.S.