July 13, 2022 — Ancora Heart, Inc., a company developing a novel device-based therapy to address heart failure, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the AccuCinch Ventricular Restoration System. Currently being evaluated in the CORCINCH-HF pivotal clinical trial, the AccuCinch System is designed to provide a minimally invasive treatment option for patients who have symptomatic heart failure (HF) with reduced ejection fraction (HFrEF).
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 healthcare providers have more timely access to these medical devices.
As the only completely transcatheter procedure to treat the enlarged left ventricle, the AccuCinch System is a fundamentally different and innovative device-based therapy designed 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 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,” said Ulrich P. Jorde, MD, professor of medicine, Albert Einstein College of Medicine, and 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.1 “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.”
An estimated 6.5 million U.S. adults live with heart failure, a condition in which the heart’s muscles weaken and lose their ability to pump enough oxygen-rich blood to the body.2 Heart failure patients suffer from debilitating symptoms including persistent exhaustion, trouble breathing, leg swelling, and confusion. About half of HF patients have heart failure with a reduced ejection fraction (HFrEF) and an enlarged left ventricle, the main pumping chamber of the heart, which causes more stress on the heart and leads to reduced pumping efficiency. About 50 percent of people who develop heart failure die within five years of diagnosis.3
“Ancora Heart is dedicated to developing solutions that address the unmet need for improved treatment options for heart failure patients,” said Jeff Closs, president and CEO of Ancora Heart. “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.”
About the AccuCinch Ventricular Restoration System and the CORCINCH-HF Pivotal Trial
The AccuCinch System is an investigational device designed to augment the existing care cardiologists provide their heart failure (HF) patients. For patients in whom HF has progressed beyond the ability of medications and pacemakers to manage symptoms, the AccuCinch System may provide a new treatment option to fill the gap between medication or pacemaker therapy and left ventricular assist devices (LVADs) or a heart transplant.
During the minimally invasive transcatheter AccuCinch System 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. By directly treating the left ventricle, the AccuCinch System may help reduce symptoms, improve quality of life and potentially increase life expectancy.
The CORCINCH-HF pivotal trial is underway, designed to evaluate the safety and efficacy of the AccuCinch Ventricular Restoration System in patients who have symptomatic heart failure (HF) with reduced ejection fraction (HFrEF). (ClinicalTrials.gov Identifier: NCT04331769). This study is being conducted to support the submission of a Premarket Approval (PMA) application to the U.S. Food and Drug Administration.
For more information: https://www.ancoraheart.com/
1 Dr. Jorde received compensation from Ancora Heart for a speaking engagement in 2020
2 Murphy S, Ibrahim N, Januzzi J. Heart Failure with Reduced Ejection Fraction, A Review. JAMA. 2020;324(5):488-504
3 Virani SS, Alonso A, Benjamin EJ, Bittencourt MS, Callaway CW, Carson AP, et al. Heart disease and stroke statistics—2020 update: a report from the American Heart Association. Circulation. 2020;141(9):e139-596.