OR YEHUDA, Israel, Sept. 20, 2018 /PRNewswire/ -- Cardiovalve announced today that it has commenced the AHEAD US multicenter study (U.S. Early Feasibility Study of High Surgical Risk Patients with Severe Mitral Regurgitation Treated with the Cardiovalve Transfemoral Mitral Valve System). AHEAD US trial recruitment will start in early Q4 2018. The primary endpoint of the study is the safety and feasibility of the Cardiovalve System in reducing mitral regurgitation, with evaluation 30 days and continuing for two years. A multicenter European study, AHEAD EU, also has initiated recruitment, starting in Switzerland with later expansion to Italy, France and Germany.
The AHEAD US study is being conducted in collaboration with the Clinical Trials Center and the Cardiovascular Research Foundation (CRF, New York), led by Dr. Ori Ben-Yehuda. "We are delighted to have received approval from regulatory agencies to commence the Early Feasibility Study for the Cardiovalve," Dr. Ben-Yehuda said. "The design of this valve and its delivery system shows significant promise in reducing the complexity of trans-catheter mitral valve replacement and enhancing the safety and outcomes of these procedures."
At the upcoming Transcatheter Cardiovascular Therapeutics conference (TCT 2018, September 21–25, San Diego), details of the first-in-man Cardiovalve procedure with the transfemoral mitral valve system will be presented by Cardiovalve Chief Medical Director, Prof. Francesco Maisano of the University Hospital Zurich.
"I am excited to share the experience of performing this novel procedure and its outcomes with my colleagues at the TCT meeting in San Diego," said Prof. Maisano. "The transfemoral approach to implantation was very straightforward, controlled and reassuring. I believe that ultimately, Cardiovalve will change how mitral valve replacement is practiced in the clinical setting."
Attendees of TCT 2018 are invited to the presentation, "Early TMVR Feasibility and Pivotal Trials," on Monday, September 24 in Room 1, Upper Level, from 8:57 a.m. – 10:34 a.m. In this presentation, physicians will learn more about the upcoming AHEAD US study and early clinical outcomes from the AHEAD EU study.
The flagship Cardiovalve system is a novel mitral valve designed for transfemoral/ transseptal use and intended to replace the mitral valve using a minimally invasive procedure, avoiding the need for transapical delivery with mini-thoracotomy access. The Cardiovalve system offers significant benefits, including a short profile for minimal protrusion to the left ventricle, minimizing interference in the cardiac blood flow (outflow tract obstruction) and increasing safety; a robust anchoring mechanism; and an enhanced sealing solution to prevent paravalvular leaks.
Mitral Valve Pioneers
Cardiovalve is pioneering the field of mitral valve replacement, an important treatment for mitral valve disease, and a common clinically significant valvular abnormality. The company's dedicated team of experts is working to bring a viable, clinically proven transfemoral alternative to open-heart surgery to market. Cardiovalve has partnered with some of the leading cardiologists in the world to transform this vision into a reality where mitral regurgitation treatments are efficient for physicians to perform, and patients have the option of quicker recovery and a more rapid return to a healthy life. Originally part of Valtech Cardio, which was acquired by Edwards Lifesciences in 2017, Cardiovalve operates under the leadership of Amir Gross, Valtech's co-founder and CEO. The company is evaluating the safety and performance of its system in clinical studies and will seek both EU and U.S. approvals.
Senior Account Director, Pascale Communications, LLC