Hangzhou, China, Jan. 31, 2024 --Venus Medtech (02500. HK), a leading provider of integrated solutions for transcatheter structural heart valvular therapies in China, announced today that, VenusP-Valve, the company's in-house developed innovative transcatheter pulmonic valve replacement (TPVR) system, cleared approval from Health Canada.
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.
"VenusP-Valve is able to eliminate pulmonary regurgitation in a wide range of anatomies," said Prof. Lee Benson, Director of Cardiac Diagnostic and Interventional Unit at the Hospital for Sick Children in Toronto, Canada. "Available in different sizes and specifications, the product offers extensive applicability to meet the clinical needs of a larger pulmonary regurgitation patient population."
Clinical data reveals that VenusP-Valve demonstrates safety and efficacy on par with similar products, and excels in aspects such as rates of reintervention and arrhythmia. According to three-year follow-up data of the European clinical trial, the success rate for TPVR with VenusP-Valve is 100%. All-cause mortality and reintervention rates 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.The data suggest excellent performance, robust safety and reliability, and drastic and steady improvements in patients' cardiac function.
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. In 2023, after receiving Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA), VenusP-Valve gained its first ethical approval in the territory, setting the stage for the VenusP-Valve PROTEUS pivotal clinical trial. More recently, the U.S. Centers for Medicare & Medicaid Services (CMS) also granted coverage approval for the PROTEUS study... Venus Medtech's Press Release -
