Venus Medtech (Hangzhou) Inc. (Venus Medtech, 02500.HK), a leading company in transcatheter structural heart valve therapies in China, has announced the successful initial implantations of its next-generation balloon-expandable dry-tissue transcatheter aortic valve replacement (TAVR) system, Venus-Vitae.

These procedures, part of the global multicenter pivotal trial Venus-Vitae SMART-ALIGN, were conducted at Prince of Wales Hospital in Hong Kong, China.

This achievement represents a significant advancement for the company in the field of dry-tissue valve technology and expands its range of transcatheter heart valve solutions.

The Venus-Vitae SMART-ALIGN trial will extend to approximately 20 centers in Europe, North America, and China, with a planned enrollment of 150 patients. The data gathered from this trial will support registration applications in the EU, Canada, China, and other regions.

The implantations were performed by a team at Prince of Wales Hospital in collaboration with specialists from the University of Virginia Medical Center.

The multidisciplinary team involved included experts from Ultrasound, Anesthesiology, and Imaging Departments. The patients received 23mm Venus-Vitae implants, and the procedures demonstrated positive immediate post-operative results with significant hemodynamic improvements.

The Venus-Vitae SMART-ALIGN trial, short for Multicenter Pivotal Study to Evaluate the Treatment of Severe Aortic Valve Stenosis Using the Venus-Vitae Transcatheter Heart Valve System, is designed to assess the safety and efficacy of the Venus-Vitae TAVR system in patients with severe aortic stenosis.

The Venus-Vitae valve is noted for its compact stent frame, one of the shortest among current options, which may improve treatment for aortic stenosis while maintaining coronary access.

Additionally, its dry valve leaflet technology allows for faster preoperative preparation. The trial is expected to expand internationally, bringing this innovative technology to a broader patient population.

Venus Medtech remains committed to advancing the Venus-Vitae system through global clinical trials and regulatory approvals, aiming to deliver this cutting-edge technology to healthcare providers and patients worldwide.


 

 

Source: prnewswire.com

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