Venus Medtech is advancing First-in-Man (FIM) studies for its self-developed next-generation transcatheter aortic valve replacement (TAVR) system Venus PowerX™ in China and beyond. As the world’s first fully-released, retrievable and self-expanding dry-tissue valve, Venus-PowerX™ recently completed three FIM cases in Argentina, stepping up overseas registration with further validation.

The three procedures were performed by Prof. Jorge Baccaro and his team at Institute of Cardiology of Corrientes (ICC), Argentina, under online support of Prof. Chen Mao from Department of Cardiology, West China Hospital, Sichuan University, and Prof. Scott Lim from Advanced Cardiac Valve Center, University of Virginia.

As the earliest clinical use of Venus-PowerX™ outside China, the study gives weight to the clinical demand and value of the product. Earlier on, Venus-PowerX™ completed its first FIM study at West China Hospital, Sichuan University.

Case 1:

Male, age 71, mean aortic annulus diameter 25.9mm according to CT scanning, diagnosed with severe aortic stenosis with heavy calcification. The patient underwent successful implantation of a 29mm Venus-PowerX™ with good procedural results. The aortic valve shows no paravalvular leak or central regurgitation postoperatively.

Case 2:

Female, age 74, mean aortic annulus diameter 24.4mm according to preoperative CT scanning, diagnosed with aortic stenosis with moderate calcification. It is worth mentioning that after fully releasing the Venus-PowerX™, Prof. Jorge Baccaro 100% retrieved and redelivered the valve after the complete release drawing on its unique design. The patient underwent successful implantation of a 29mm Venus-PowerX™ with good procedural results. The aortic valve shows no paravalvular leak or central regurgitation postoperatively.

Case 3:

Female, age 88, mean aortic annulus diameter 21.5mm according to preoperative CT scanning, diagnosed with aortic stenosis with moderate to severe calcification. The patient underwent successful implantation of a 26mm Venus-PowerX™ with good procedural results. The aortic valve shows no paravalvular leak or central regurgitation postoperatively.

As our in-house developed dry-tissue valve, Venus-PowerX™ utilizes an advanced anti-calcification process and is suitable for room temperature storage. The mechanical properties of the valve will not be damaged due to dehydration during storage, which in turn improves valve durability. In addition, the dry-tissue valve can be pre-mounted and contains no aldehyde residue, thereby enhancing safety while facilitating clinical use and valve storage and transport.

Venus-PowerX™ also features a wire-controlled design that allows retrieval of the valve after 100% complete release to improve safety. In addition, its delivery system adopts a new sheath design that optimizes its flexibility to go through the aortic arch. The valve frame is simplified to reserve coronary access with three V-shaped designs while retaining radial force.

Notably, Venus-PowerX™ uses materials enhanced with intelligent active anti-paravalvular leak (anti-PVL) technology to provide an effective anti-PVL solution for patients. The proprietary expandable material actively reduces perivalvular leak between the prosthetic valve and the native annulus. Also, it will not cause problems such as increased delivery system profile triggered by physical skirt or skirt damage from retrieval.

Prof. Jorge Baccaro highly praised the self-expanding dry-tissue valve by Venus Medtech,“Venus-PowerX™ provides excellent flexibility to go through the aortic arch and easy delivery. The patients have no paravalvular leak thanks to its adaptive anti-PVL skirt. Its unique wire-controlled design allows retrieval of the valve after 100% complete release, which is particularly important to challenging TAVR cases.”

Prof. Chen Mao said, “I’m very pleased to be part of the overseas clinical trials of Venus-PowerX™. This is another milestone it has reached after the first FIM study at West China Hospital. The specially designed valve can be pre-mounted to shorten procedure preparation and enhance valve durability. The product is also seeing smooth progress in domestic trials.”

 

Prof. Scott Lim indicated, “It’s a true honor to work with Prof. Jorge Baccaro of ICC and Prof. Chen Mao of West China Hospital on the first clinical use of Venus-PowerX™ outside China. Venus-PowerX™ is a new-generation self-expanding dry-tissue TAVR product. It utilizes an advanced anti-calcification process that improves the durability of prosthetic valve. The product can be pre-mounted to greatly reduce preoperative loading time, which gives it an impressive advantage over competitors worldwide.”

 

Eric Zi, Founder and General Manager of Venus Medtech said, “As a major country in South America, Argentina is an important market in our global coverage. It facilitates the overseas launch of Venus-PowerX™, our in-house developed new-generation self-expanding dry-tissue valve, to have successfully completed these FIM cases. Looking ahead, we are confident to bring our novel products to the global market, benefitting more doctors and patients.”