Onecrea Medical completes first-in-human implants of TAVR system

2023-07-21

临床研究

The company designed its next-generation TAVR system to treat aortic stenosis. With a unique concave and convex structure, the TAVR system anchors the valve effectively in the aortic annulus. This helps to avoid common complications with TAVR, including implant dislodging or perivalvular leak (PVL) due to improper fit, according to the company. The valve also features differential radial force in different parts, according to a news release. It imparts low or high radial forces to the valve depending on the location within the annulus and aorta. Onecrea said it designed the delivery system with improvements for greater control and accuracy for implantation. About the first-in-human implants for Onecrea Medical Dr. Carlos Calderas supervised a team of surgeons that performed the implantations for the first-in-human effort for the Onecrea valve. The first patient, an 82-year-old woman, had a history of severe shortness of breath and severe symptomatic aortic stenosis. She underwent a giant abdominal aortic aneurysm (AAA) repair recently. Calderas successfully implanted a 26 mm Crea aortic valve through the femoral approach. The patient was discharged from the hospital after three days with a mean gradient of 8 mmHg and no PVL. Onecrea said that the second patient, an 88-year-old-woman, was referred to consider TAVR because of severe symptomatic aortic stenosis. She recently went to the emergency room for heart failure requiring mechanical ventilation. This led to a diagnosis of severe aortic stenosis and shortness of breath. The team implanted a 26 mm Crea valve through the femoral approach with the 18F introducer. At discharge five days later, the patient recorded a mean gradient of 7 mmHg and no PVL. “The design of the Crea Aortic Valve is truly exceptional, revolutionizing the way we approach TAVR procedures,” Calderas said. “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 paravalvular leaking and implant dislodging. The valve’s innovative engineering ensures optimal hemodynamics and durability, providing patients with a reliable and long-lasting solution.” Onecrea continues to enroll patients in a larger clinical study conducted across multiple centers.

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