SANTA ROSA, Calif.--(BUSINESS WIRE)--Direct Flow Medical®, Inc., a transcatheter heart valve innovator focused on improving patient outcomes, today announced it has completed enrollment in the U.S. SALUS trial of the Direct Flow Medical Transcatheter Aortic Heart Valve System. The SALUS trial is a study to assess the safety of the Direct Flow Medical system to treat patients with severe aortic stenosis who are at extreme risk for surgical aortic valve replacement (SAVR). The Direct Flow Medical valve is the first transcatheter aortic valve designed to meaningfully improve aortic regurgitation outcomes that has been studied in a U.S. clinical trial. Direct Flow Medical is working closely with the Food and Drug Administration (FDA) and plans to initiate a U.S. pivotal trial in 2014.
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