Ancora Heart announced today that it received FDA breakthrough device designation for its AccuCinch ventricular restoration system.
Santa Clara, California-based Ancora Heart designed its AccuCinch system to provide a minimally invasive treatment option for patients who have symptomatic heart failure (HF) with reduced ejection fraction (HFrEF). The company is currently evaluating the system in the Corcinch-HF pivotal clinical trial.
According to a news release, as the only completely transcatheter procedure for treating the enlarged left ventricle, AccuCinch offers a fundamentally different and innovative device-based therapy for improving the structure and function of the heart, helping to bring relief to HF patients who remain symptomatic despite current guideline-directed medical care.
“The chronic and progressive nature of heart failure 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,” Dr. Ulrich P. Jorde, professor of medicine at the Albert Einstein College of Medicine, section head of Heart Failure, Cardiac Transplantation and Mechanical Circulatory Support at Montefiore Health System in New York and global co-principal investigator of the Corcinch-HF study, said in the release. “Early data on the AccuCinch system are promising, providing hope that this novel transcatheter approach may address the therapeutic gap for heart failure patients in the future.”
Ancora Heart said that AccuCinch may provide a new treatment option to fill the gap between medication or pacemaker therapy and left ventricular assist devices (LVADs) or heart transplant. During the procedure, a flexible implant is attached to the inner wall of the left ventricle, then sinched.
The implant is intended to reduce the size of the left ventricle, reduce ventricular wall stress and support and strengthen the heart wall. Through direct treatment to the left ventricle, the AccuCinch System may help reduce symptoms, improve quality of life and potentially increase life expectancy.
“Ancora Heart is dedicated to developing solutions that address the unmet need for improved treatment options for heart failure patients,” Ancora Heart President and CEO Jeff Closs said. “The breakthrough designation is a valuable step in the pathway to FDA approval and we look forward to continuing to work closely with the agency in order to make the AccuCinch system available to these patients.”