FDA Approves Expansion of Ancora Heart's Feasibility Study for the AccuCinch System

May 14, 2018—Ancora Heart, Inc. announced that the US Food and Drug Administration has approved the expansion of the company’s United States feasibility study that is evaluating the investigational AccuCinch ventricular repair system designed for the treatment of heart failure and functional mitral regurgitation (FMR). The company has received approval to enroll a second group of patients in the study and expand to 15 heart centers across the United States.

According to Ancora Heart, AccuCinch is intended to directly repair the enlarged left ventricle, targeting the underlying cause of heart failure. The minimally invasive procedure is designed to reduce the size of the left ventricle, improve left ventricular function, and reduce symptoms of heart failure, with the goal of improving quality of life for patients. This therapy has the potential to treat patients with heart failure and FMR in whom the disease has progressed beyond the ability for medications and pacemakers to manage symptoms or for whom the risks of open heart surgery are too high, stated the company.

In the company's announcement, Paul Sorajja, MD, commented, “Today, there is an enormous unmet need for effective treatment options for patients with heart failure, as many patients either do not undergo or may not benefit from traditional surgical approaches. Early results suggest that AccuCinch has the potential to be the first therapy of its kind to treat dysfunction of the left ventricle and indicate this approach may address the shortcomings of current heart failure and FMR treatments.” Dr. Sorajja is the Roger L. and Lynn C. Headrick Family Chair for Valve Science Research at the Minneapolis Heart Institute Foundation Valve Science Center in Minneapolis, Minnesota. He serves as Principal Investigator for the study at Minneapolis Heart.