Recently, Venus Medtech (Hangzhou) Inc. ("Venus Medtech"), a leading provider of integrated solutions for transcatheter structural heart valvular therapies in China, announced the Investigational Device Exemption (IDE) full approval for its in-house developed VenusP-Valve from the U.S. Food and Drug Administration (FDA). VenusP-Valve, thus, has become the first China-developed heart valvular system to be approved by the FDA for clinical trial, setting a new milestone in the global footprint of Chinese valves.

IDE refers to the exemption of medical devices intended for marketing from regulatory requirements, allowing clinical trials to be conducted on such devices. The announced IDE approval will allow VenusP-Valve to initiate pivotal clinical trials in the U.S. to support the Pre-Market Approval (PMA). Through the Japan-US Harmonization By Doing program, jointly established by the FDA and Japan's PMDA, this clinical trial will be conducted concurrently at 10 centers in the U.S. and 5 centers in Japan, and 60 patients are expected to be enrolled. Last year, VenusP-Valve was applied in two cases for compassionate use in the U.S.

As the company's international flagship product, VenusP-Valve received CE marking under the Medical Devices Regulation (MDR) on April 8th, 2022, becoming the first Class III implantable cardiovascular device approved under the new MDR. To date, VenusP-Valve has been approved in more than thirty countries including China, the United Kingdom, Italy, Spain, Denmark, Greece, France, Germany, Poland, Switzerland, etc., and its implantations enjoy continuous growth in new hospitals and centers.

As the first self-expanding TPVR product approved in China and Europe, VenusP-Valve carries remarkable clinical value. Uniquely designed with both flared ends, the product ensures the blood flow of branchial artery with bare stents at the outflow end. It provides a stable multi-point anchoring system and enables easy delivery, with no need for pre-stenting before the procedure. Available in a variety of specifications with extensive applicability, VenusP-Valve is able to meet the needs of 85% of patients in the case of large RVOT.

According to three-year follow-up data of the European clinical trial, the success rate for TPVR with VenusP-Valve is 100% in 64 patients (some patients have not been included due to the COVID-19 pandemic). All-cause mortality and surgical reintervention rate were zero. In addition, no moderate or severe pulmonary regurgitation was observed. Paravalvular leakage and tricuspid regurgitation were mild or below in 96.87% of subjects.

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