Onecrea Medical has announced the success of the first-in-human implants of its transcatheter aortic valve implantation (TAVI) system for the treatment of aortic stenosis. The procedures were performed by a team under the supervision of Carlos Calderas (Policlinica Metropolitana, Caracas, Venezuela).
Onecrea Medical’s valve has a concave and convex structure that anchors the valve in the aortic annulus, in order to address paravalvular leak (PVL). The valve also features differential radial force in different parts, imparting low or high radial forces to the valve depending on the location within the annulus and aorta.
In addition, the delivery system has been designed for greater control and accuracy of valve implantation. The valves have been tested for over 200 million fatigue cycles and over 140 days in animal trials.
Calderas commented: “The design of the Crea aortic valve is truly exceptional, revolutionising the way we approach TAVI procedures. The delivery system was remarkably easy to use, increasing the accuracy of valve placement. This means less time operating on the patient while decreasing the risk of PVL and implant dislodging. The valve’s innovative engineering ensures optimal haemodynamics and durability, providing patients with a reliable and long-lasting solution.”
Patient one was an 82-year-old woman with a history of severe shortness of breath, severe symptomatic aortic stenosis, who had recently undergone abdominal aortic aneurysm (AAA) repair. Calderas implanted a 26mm Crea Aortic Valve through the femoral approach successfully and the patient was discharged from the hospital after three days with a mean gradient of 8mmHg and no PVL.
The second patient was an 88-year-old woman, referred for potential TAVI due to severe symptomatic aortic stenosis. She was recently admitted to the emergency room for heart failure requiring mechanical ventilation and diagnosed with severe aortic stenosis and shortness of breath. A 26mm Crea aortic valve was implanted from the femoral approach using the 18Fr introducer. The patient was discharged after five days with a mean gradient of 7mmHg and with no PVL.
Onecrea Medical is currently enrolling more patients in a larger clinical study conducted across multiple centres.