Health Canada Approves Venus Medtech's VenusP-Valve Transcatheter Pulmonic Valve Replacement System

Tuesday, February 06, 2024

Venus Medtech, a leading provider of integrated solutions for transcatheter structural heart valvular therapies based in China, has announced the clearance of its innovative transcatheter pulmonic valve replacement (TPVR) system, the VenusP-Valve, by Health Canada. This marks a significant milestone as VenusP-Valve becomes the first self-expanding TPVR product approved not only in China but also in Europe.

The VenusP-Valve features a unique design with flared ends to ensure optimal blood flow in the branchial artery, while bare stents at the outflow end enhance stability. Its multi-point anchoring system offers stability during delivery without the need for pre-stenting. With various specifications, VenusP-Valve caters to approximately 85% of patients with large RVOT, making it highly adaptable.

Clinical data reveals that VenusP-Valve demonstrates safety and efficacy comparable to similar products, with favorable outcomes in terms of reintervention rates and arrhythmias. Notably, the three-year follow-up data from the European clinical trial indicates a 100% success rate for TPVR with VenusP-Valve, with minimal complications observed.

Furthermore, VenusP-Valve has received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA), paving the way for the VenusP-Valve PROTEUS pivotal clinical trial. Recently, the U.S. Centers for Medicare & Medicaid Services (CMS) granted coverage approval for the PROTEUS study.

VenusP-Valve has also been included in national health insurance programs in several countries and has obtained approval in over fifty countries worldwide, including China, Germany, France, the United Kingdom, Italy, and Spain. Its adoption continues to grow in new hospitals and centers globally, indicating its increasing acceptance and use in clinical practice.