Sam Brusco, Associate Editor07.18.22
Ancora Heart has obtained U.S. Food and Drug Administration breakthrough status for its AccuCinch ventricular restoration system.
The system is currently being assessed in the CORCINCH-HF pivotal trial. It’s designed for minimally invasive treatment for symptomatic heart failure (HF) with reduced ejection fraction (HFrEF).
AccuCinch is the only completely transcatheter procedure to treat the enlarged left ventricle, according to the company. It is designed to improve the heart’s structure and function and help bring relief to HF patients remaining symptomatic despite guideline-directed 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,” 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, told the press. “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.”
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.
“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.”
The system is currently being assessed in the CORCINCH-HF pivotal trial. It’s designed for minimally invasive treatment for symptomatic heart failure (HF) with reduced ejection fraction (HFrEF).
AccuCinch is the only completely transcatheter procedure to treat the enlarged left ventricle, according to the company. It is designed to improve the heart’s structure and function and help bring relief to HF patients remaining symptomatic despite guideline-directed 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,” 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, told the press. “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.”
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.
“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.”