VenusP-Valve by Venus MedTech Becomes First Chinese Transcatheter Pulmonary Valve Approved for Clinical Trial in the U.S.

Recently, Hangzhou Venus MedTech Co., Ltd. (“Venus MedTech”), a leading provider of comprehensive solutions for structural heart disease in China, announced that its independently developed transcatheter pulmonary valve replacement (TPVR) system, VenusP-Valve, has received full approval without additional conditions for its Investigational Device Exemption (IDE) application from the U.S. Food and Drug Administration (FDA). VenusP-Valve has become the first Chinese-made artificial heart valve approved by the FDA for clinical trials, setting a new record for Chinese heart valves going global.

An Investigational Device Exemption (IDE) waives certain regulatory requirements for medical devices intended for commercial distribution, thereby permitting their use in clinical trials. Approval of the IDE application enables VenusP-Valve to initiate pivotal clinical studies in the United States, providing supporting data for Pre-Market Approval (PMA). Through the Japan-US Harmonization By Doing program jointly established by the U.S. FDA and Japan’s PMDA, this clinical trial will be conducted simultaneously at 10 medical centers in the United States and 5 medical centers in Japan, with an expected enrollment of 60 patients. According to the plan, patient enrollment for VenusP-Valve will commence in the United States in the second half of this year and in Japan in early 2024, with simultaneous market approval in both countries anticipated around 2026.

The VenusP-Valve is the company’s flagship product for international expansion. It received CE MDR certification from the European Union on April 8, 2022, becoming the first Class III cardiovascular implantable medical device approved under the new regulations. To date, the VenusP-Valve has been launched in more than 30 major countries, including China, the United Kingdom, Italy, Spain, Denmark, Greece, France, Germany, Poland, and Switzerland, with surgical implants continuously being performed in newly covered medical institutions. Last year, two humanitarian use cases of the VenusP-Valve were completed in the United States.

As the first self-expanding transcatheter pulmonary valve replacement (TPVR) product approved for marketing in both China and Europe, VenusP-Valve demonstrates significant clinical value. Its unique double-flared design, combined with a bare-stent configuration at the outflow end to preserve branch vessel perfusion, ensures stable multi-site anchoring. The device is easy to deploy and does not require pre-placement of a fixation stent prior to implantation. With a wide range of available sizes and broad applicability, it meets the clinical needs of over 85% of patients requiring large-diameter pulmonary valve replacement.

Three-year European follow-up data for the VenusP-Valve showed a 100% procedural success rate among 64 patients who underwent transcatheter pulmonary valve replacement (TPVR) (with some patients excluded due to the COVID-19 pandemic). All-cause mortality and reintervention rates were both 0%, and no patients experienced moderate or severe pulmonary regurgitation. Perivalvular leak and tricuspid regurgitation were mild or less in 96.87% of the subjects.