Cardiovalve launches pivotal TMVR trials

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 Transcathet...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cardiac Implants Cardiovascular Clinical Trials Replacement Heart Valves cardiovalve Source Type: news