Venus Medtech (Hangzhou) Inc. (HKG: 2500) has announced obtaining Investigational Device Exemption (IDE) approval from the US FDA for its VenusP-Valve, marking a significant step as the first China-developed heart valvular system to be approved by the FDA for clinical trial. IDE approval is a critical exemption that allows medical devices intended for marketing to bypass certain regulatory requirements, enabling clinical trials to be conducted.
Initiation of Pivotal Clinical Trials in the US and Japan
The IDE approval paves the way for VenusP-Valve to initiate pivotal clinical trials in the US, supporting the Pre-Market Approval (PMA) process. In conjunction with the Japan-US Harmonization By Doing program, established by the FDA and Japan’s PMDA, the clinical trial will be conducted across 10 centers in the US and 5 centers in Japan, with an expected enrollment of 60 patients.
VenusP-Valve’s Global Recognition and CE Marking
VenusP-Valve, the first self-expanding transcatheter pulmonary valve replacement (TPVR) product approved in China and Europe, received CE marking under the Medical Devices Regulation (MDR) on April 8th, 2022. The product is distinguished by its stable multi-point anchoring system and ease of delivery, eliminating the need for pre-stenting before the procedure. Since its approval, VenusP-Valve has been granted regulatory approval in over thirty countries, including China, the United Kingdom, Italy, Spain, Denmark, Greece, France, Germany, Poland, and Switzerland, with continuous growth in new hospital and center implantations.-Fineline Info & Tech
