Health Canada has approved China-based Venus Medtech’s VenusP-Valve transcatheter pulmonic valve replacement (TPVR) system.
Said to be the first self-expanding TPVR product approved in China and Europe, the VenusP-Valve is a Class III implantable cardiovascular device.
The device is designed to ensure blood flow in the branchial artery with bare stents at the outflow end and provide a stable anchoring system without the need for pre-stenting.
Clinical trials have shown the VenusP-Valve to be safe and effective, with a 100% success rate reported in European trials.
The three-year follow-up data indicated no all-cause mortality or reintervention rates, and no moderate or severe pulmonary regurgitation was observed.
Venus Medtech CEO Lim Hou-Sen said: “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.
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“The approval of VenusP-Valve represents a meaningful expansion of clinical options for patients in the country.”
The VenusP-Valve received CE marking under the Medical Devices Regulation (MDR) in April 2022 and secured investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) last year.
Venus Medtech said that the VenusP-Valve device is now approved in more than 50 countries, including China, Germany, France, the UK, Italy, and Spain.
Hospital for Sick Children in Toronto, Canada cardiac diagnostic and interventional unit director Lee Benson said: “VenusP-Valve is able to eliminate pulmonary regurgitation in a wide range of anatomies.
“Available in different sizes and specifications, the product offers extensive applicability to meet the clinical needs of a larger pulmonary regurgitation patient population.”