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Novostia presents outstanding animal study results
Animal study results are presented by Prof. Bart Meuris during the Heart Valve Society (HVS) Meeting 2021
Heart valves prostheses still face limitations: reoperations with tissue valves or lifelong anticoagulation with mechanical valves. The Triflo valve, a tri-leaflet valve made of high-resistant bio-inert materials, aimed at overcoming these limitations. We studied safety and performance in a chronic sheep model. The Triflo valve was implanted in two models: aortic position and pulmonary position. The Triflo valve demonstrated excellent surgical handling. In pulmonary position all sheep recovered fast and remained in excellent clinical condition until the scheduled sacrifice. In aortic position, we observed low peak and mean gradients, high effective orifice area, no valvular regurgitation, and perfect left ventricular function. At explantation, the surface of all Triflo valves was clean, without any valve thrombosis. All major organs were free from thrombo-embolic (TE) damage. In pulmonary position, leaflet mobility of all valves remained also normal and no TE-damage was found in the lungs. Hematological parameters were stable without any sign of hemolysis. On-X valves in pulmonary position functioned well, but generated significantly louder acoustic signals.
The Triflo valve showed safety and effectiveness in both aortic and pulmonary position. These favorable in-vivo results, with excellent hemodynamic behavior and stable long-term function even in the absence of anticoagulants, demonstrate that this valve can proceed to first-in-human studies.