FDA Gives Breakthrough Device Designation to Ancora Heart’s AccuCinch

The FDA granted Santa Clara, Calif.-based Ancora Heart a Breakthrough Device designation for its AccuCinch ventricular restoration system.

The device is intended to provide a minimally invasive treatment option for patients who have symptomatic heart failure with reduced ejection fraction.

During the procedure, a flexible implant is attached to the inner wall of the left ventricle and then cinched to reduce the size of the left ventricle, reduce ventricular wall stress and support and strengthen the heart wall.

By directly treating the left ventricle, the AccuCinch System may help reduce symptoms, improve quality of life and potentially increase life expectancy, the company said.

The Breakthrough Device program is meant to provide more timely access to the devices by speeding up their development and review.