Ancora Heart’s AccuCinch Ventricular Restoration System Receives FDA Breakthrough Device Designation

July 12, 2022—Ancora Heart, Inc. announced that the FDA has granted Breakthrough Device designation to the company’s AccuCinch ventricular restoration system. The AccuCinch system is designed to provide a minimally invasive treatment option for patients with symptomatic heart failure (HF) with reduced ejection fraction (HFrEF).

According to the company, the AccuCinch system is intended to improve the structure and function of the heart and help bring relief to HF patients who remain symptomatic despite current guideline-directed medical care.

The device uses a completely transcatheter procedure to treat the enlarged left ventricle. In the procedure, a flexible implant is attached to the inner wall of the left ventricle and then cinched. The implant is intended to reduce the size of the left ventricle, reduce ventricular wall stress, and support and strengthen the heart wall.

The safety and efficacy of the AccuCinch is currently being evaluated in the in patients with symptomatic HFrEF in the CORCINCH-HF pivotal clinical trial. This study is being conducted to support the submission of premarket approval application to the FDA.

Ulrich P. Jorde, MD, is Global Coprincipal Investigator of the CORCINCH-HF study, Professor of Medicine at Albert Einstein College of Medicine, and Section Head of Heart Failure, Cardiac Transplantation, and Mechanical Circulatory Support at Montefiore Health System in New York.

In Ancora Heart’s press release, Dr. Jorde commented, “The chronic and progressive nature of HF leaves many patients to face an increasingly challenging future as existing treatments, including medications and pacemaker devices, are not able to keep the disease at bay. Early data on the AccuCinch system are promising, providing hope that this novel transcatheter approach may address the therapeutic gap for HF patients in the future.”

The company noted that the FDA Breakthrough Devices program expedites the development, assessment, and review process for certain medical devices that provide for more effective treatment options for patients with life-threatening or irreversibly debilitating diseases or conditions. This program is designed to ensure patients and health care providers have more timely access to these medical devices.