Israel cardiovascular device developer Cardiovalve said yesterday it launched both the Ahead US and Ahead EU multicenter studies of its Cardiovalve transfemoral mitral valve replacement system.
The company’s flagship Cardiovalve system is a novel mitral valve designed for either transferal or transeptal use and is intended to replace the mitral valve through a minimally invasive procedure. Cardiovalve touted that the device features a short profile for minimal protrusion to the left ventricle and minimized interference in cardiac blood flow.
Cardiovalve said that will begin enrollment in the Ahead US trial early in the fourth quarter of this year, evaluating patients at 30 days with follow-ups continuing out to two years. The company said it also began recruitment of its Ahead EU trial in Switzerland with plans to expand to Italy, France and Germany.
The company said that it will use data from its clinical trials to seek clearance in both the European Union and the US.
“We are delighted to have received approval from regulatory agencies to commence the early feasibility study for the Cardiovalve. 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,” study lead Dr. Ori Ben-Yehuda said in a press release.
Cardiovalve said that it plans to present results from its first-in-man Cardiovalve procedure at the Transcatheter Cardiovascular Therapeutics conference this week
“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. 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,” Dr. Francesco Maisano of the University Hospital Zurich, who will present the data at TCT, said in a prepared statement.