Ancora Heart this week said it has enrolled the first patient in its AccuCinch Ventricular Restoration System pivotal trial.
AccuCinch is a flexible implant that is attached to the inner wall of the left ventricle and then cinched. It is designed to reduce the size of the left ventricle, reduce ventricular wall stress and support and strengthen the heart wall.
The Corcinch-HF pivotal trial will evaluate the safety and efficacy of the system in patients who have symptomatic heart failure with reduced ejection fraction. The study is being conducted to support the company’s premarket approval application for the FDA.