3/6/2023 0 Comments Ancora heart![]() 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.”Īn estimated 6.5 million U.S. 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. “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. This program is designed to ensure patients and healthcare providers have more timely access to these medical devices.Īs 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 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. 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). Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the AccuCinch ® Ventricular Restoration System. “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.SANTA CLARA, Calif.-( BUSINESS WIRE)- Ancora Heart, Inc., a company developing a novel device-based therapy to address heart failure, today announced that the U.S. “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. Through direct treatment to the left ventricle, the AccuCinch System may help reduce symptoms, improve quality of life and potentially increase life expectancy. The implant is intended to reduce the size of the left ventricle, reduce ventricular wall stress and support and strengthen the heart wall. During the procedure, a flexible implant is attached to the inner wall of the left ventricle, then sinched. “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.”Īncora 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. 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. “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. The company is currently evaluating the system in the Corcinch-HF pivotal clinical trial.Īccording 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. 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). Ancora Heart announced today that it received FDA breakthrough device designation for its AccuCinch ventricular restoration system.
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