Venus Medtech Begins SMART-ALIGN Pivotal Clinical Study of Venus-Vitae TAVR System

September 5, 2024—China-based Venus Medtech (Hangzhou) Inc. announced the initial implantations of its Venus-Vitae next-generation balloon-expandable dry-tissue transcatheter aortic valve replacement (TAVR) system as part of the company’s Venus-Vitae SMART-ALIGN global multicenter pivotal trial.

The prospective, nonrandomized interventional study is evaluating the treatment of severe aortic valve stenosis using the Venus-Vitae TAVR system. The first two procedures in the study were performed at Prince of Wales Hospital in Hong Kong, China. Both patients received 23-mm Venus-Vitae implants, and the procedures presented good immediate post-operative results with significant hemodynamic improvement, noted the company.

According to Venus Medtech, the SMART-ALIGN pivotal trial will be progressively launched at approximately 20 centers in Europe, North America, and China. The trial will enroll a total of 150 patients. Data from the trial will be used to support registration applications in the European Union, Canada, China, and other territories.

As noted in the press release, the initial procedures in the study were performed by Professor So Chak Yu Kent, MD, and the team at Prince of Wales Hospital in collaboration with Professor Scott Lim, MD, of the University of Virginia Medical Center in Charlottesville, Virginia, and supported by a multidisciplinary team from the Ultrasound, Anesthesiology, and Imaging Departments.

In June 2024, the company announced the first implantation of its VenusP-Valve transcatheter pulmonic valve replacement system in the PROTEUS investigational device exemption pivotal clinical study that was performed by a multidisciplinary team coordinated by Prof. Lim and Professor Michael Hainstock, MD.

“Recently, my colleague Dr. Michael Hainstock and I, at the University of Virginia Medical Center, completed the first patient implantation in the VenusP-Valve PROTEUS pivotal clinical trial in the United States,” commented Prof. Lim in the company’s press release. “Two months later, I am very pleased to have participated with Dr. Kent So in the implantation of the first two patients in the Venus-Vitae SMART-ALIGN international multicenter pivotal clinical trial at Prince of Wales Hospital in Hong Kong. These both represent important milestones in those studies.”

Prof. Lim continued, “Additionally, both the VenusP-Valve and the Vitae valve have been previously used in clinical applications, with excellent published results. Of note, the Venus-Vitae valve’s stent frame is the shortest among current transcatheter aortic valves, and I am encouraged by its potential to treat aortic stenosis while maintaining coronary access. Furthermore, its dry valve leaflet technology facilitated rapid preoperative preparation time. We look forward to further international enrollment in the SMART-ALIGN clinical trial in the near future.”

Also in the press release, Prof. So commented, “It was an honor to collaborate with Dr. Scott Lim to complete the first two confirmatory clinical implantations of this innovative dry valve. Venus-Vitae’s active anti–paravalvular leak technology and short frame design effectively prevent leakage and minimize the risk of coronary artery obstruction. I’m eager to see expedited enrollment of patients for Venus-Vitae, so that more patients can benefit soon.”