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Ancora Heart 's AccuCinch Therapy Shows Positive Results In Interim Study


Ancora Heart Inc., a privately-held medical device company, on Wednesday said that its investigational non-surgical heart failure therapy AccuCinch Ventricular Repair System for the treatment of systolic heart failure showed positive results in its study dubbed CorCinch FMR.

Systolic heart failure occurs when the left ventricle of the heart, which pumps most of the blood, becomes weak due to enlargement.

AccuCinch treats heart failure by repairing the enlarged left ventricle. The percutaneous ventricular repair device is designed for the treatment of heart failure and functional mitral regurgitation(FMR).

The CorCinch FMR study involves 35 patients who were treated with the AccuCinch at 15 heart centers.

The primary safety endpoint of the study is device-related or procedure-related major adverse events through 30 days. Secondary exploratory endpoints include technical success, device and procedural success, as well as other observational endpoints measuring heart function, heart failure symptoms, and changes in quality of life.

According to the Company, data from the interim analysis indicate a favorable safety profile with 97% freedom from device-related major adverse events at 30 days. Preliminary efficacy data from the first nine patients treated with the latest implantation technique and with adjudicated core lab data available through six months demonstrated a reduction in left ventricular volume by an average of 23%. Ejection fraction, a measure of blood flowing out of the left ventricle, improved on average from 31% to 39% over the same period.

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