Ancora Heart has enrolled the first patient in its U.S. pivotal CORCINCH-HF trial, evaluating the AccuCinch Transcatheter Left Ventricular Restoration System for heart failure with reduced ejection fraction (HFrEF). The investigational device aims to reduce left ventricular size, decrease wall stress, and strengthen the heart wall. Early clinical results were presented in 2023 and the device received FDA Breakthrough Device Designation in 2022.
Dr. Ulrich Jorde, global co-principal investigator, noted that despite advances in medical therapy, many heart failure patients still suffer debilitating symptoms. The trial seeks to determine if AccuCinch can improve patients’ quality and length of life. Co-principal investigator Dr. Mark Reisman added the device targets reverse remodeling of the enlarged left ventricle to enhance heart function, reduce hospitalizations, and improve outcomes.
The study will enroll 400 patients, with six-month data from the first 250 supporting a planned FDA premarket approval submission.
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