Venus Medtech has announced that the VenusP-Valve transcatheter pulmonic valve replacement (TPVR) system has cleared approval from Health Canada.
In a press release, the company says that the device is the first self-expanding TPVR product approved in China and Europe. VenusP-Valve is designed with both flared endsto ensure the blood flow of branchial artery with bare stents at the outflow end.
The system provides a stable multi-point anchoring system and enables easy delivery, with no need for pre-stenting before the procedure, the company adds. VenusP-Valve is available in a variety of specifications with extensive applicability, and is able to meet the needs of 85% of patients in the case of large right ventricular outflow tract (RVOT), the press release adds.
“VenusP-Valve is able to eliminate pulmonary regurgitation in a wide range of anatomies,” said 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.”
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.
As the company’s international flagship product, VenusP-Valve received CE marking under the Medical Devices Regulation (MDR) in April 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 US. 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 US Centers for Medicare & Medicaid Services (CMS) also granted coverage approval for the PROTEUS study.
“Seeking effective treatments for major diseases that pose a serious threat to human health is what we do at Venus Medtech, which makes us proud to have received this Health Canada approval,” said Lim Hou-Sen, chief executive Officer of Venus Medtech. “The approval of VenusP-Valve represents a meaningful expansion of clinical options for patients in the country.”
Following its first clinical implantation in 2013 by Academician Ge Junbo, Director of Cardiology at Zhongshan Hospital, Fudan University, VenusP-Valve has been applied in clinical practice for 11 years. To date, the device has been included in national health insurance programs in Germany, France, and others and has been approved in more than 50 countries, including China, Germany, France, the UK, Italy, and Spain.
