The company’s AccuCinch System is designed to provide a minimally invasive treatment option for patients who have symptomatic heart failure.

MDDI Staff

July 14, 2022

1 Min Read
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Image courtesy of Sasin Paraksa / Alamy Stock Photo

Ancora Heart said 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).

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. “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.”

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