Venus Vitae™, Venus Medtech's next-generation balloon-expandable dry-tissue valve, recently completed three TPVR First-in-Man (FIM) cases in Argentina. This is Venus Vitae’s first-ever clinical application in the pulmonary position following its multiple successful TAVR cases, having a significant importance in expanding the clinical applicability of dry-tissue valve.

The procedures were performed at three hospitals in Argentina respectively, namely, Hospital Ricardo Gutierrez, Hospital Pedro de Elizalde, and Institute Cardiology de Corrientes. The operators included Prof. Marcelo Rivarola, Prof. Victorio Lucini, Prof. Francisco Garay and Prof. Liliana Ferrin, etc..

Case 1

Female, age 21, TOF. MPA restriction at 19mm, which increased to 22mm under balloon dilation. A 23mm Venus Vitae™ was implanted successfully in a 22mm pre-implanted stent. No pulmonary regurgitation was observed, and the valve position was good without paravalvular leak.

 

Case 2

Female, age 14, TOF. A 23mm Venus Vitae™ was implanted successfully in a 22mm pre-implanted stent. No pulmonary regurgitation was observed, and the valve position was good without paravalvular leak.

 

Case 3

Male, age 21, TOF. A 23mm Venus Vitae™ was implanted successfully in an existing stent. No pulmonary regurgitation was observed, and the valve position was good without paravalvular leak.

 

Venus Vitae™, the next-generation balloon-expandable dry-tissue valve product developed by Venus Medtech, enjoys global patent protection. Leveraging the unique Venus-Endura™ tissue, the valve provides enhanced anti-calcification and hemodynamic effects. The mechanical properties of the valve will not be damaged due to dehydration during storage, which in turn improves durability. In addition, its patented wire lock technology can ensure the valve does not shift on the balloon catheter. Meanwhile, the product utilizes a short valve frame and a smaller delivery system profile, which ensures increased flexibility to go through the aortic arch.

 

Noteworthily, Venus-Vitae™ offers excellent anti-paravalvular leak (anti-PVL) performance enabled by a smart active anti-PVL material. This proprietary expandable polymer is used to actively resist paravalvular leak between the prosthetic valve and the native annulus. Also, the material will not cause problems such as increased delivery profile triggered by physical skirt or skirt damage from retrieving valve.

 

“It was a great honor to participant in Venus Vitae’s first-ever clinical application in the pulmonary position”, commented Prof. Marcelo Rivarola after the procedure. “There was no regurgitation in the valve and the patient was very well after the procedure. Its short valve frame and a smaller delivery system profile ensured increased flexibility to go through the aortic arch and easy deployment.”

 

Prof. Francisco Garay said, “I'm very pleased to be part of the first Venus Vitae's TPVR case. The procedure was very nice and the patient recovered well. It was not complicated to mount the valve due to its dry-tissue design, which enhanced safety while facilitating clinical use and valve storage and transport. Looking forward to more cases in the near future.”

 

Prof. Francisco Garay indicated, “The procedure was technically simple, in which the wire lock system and radiopaque markers design let us implant and position the valve exactly where we wanted it. No pulmonary regurgitation was observed, and the patient was discharged 24 hours later. We’ve contacted the patient and he felt better without symptoms.”

 

Eric Zi, Founder and General Manager of Venus Medtech said, “The multiple successful applications of Venus Vitae corroborated its excellent clinical effects. Our VenusP-Valve™ was approved by CE MDR and China NMPA successively this year, which laid a solid foundation for the dry-tissue valve’s application in TPVR cases. With plans to launch Venus Vitae™ in Latin American countries, I believe the relevant clinical experience was able to provide references for the next international multi-centered clinical trials in Europe and China.”