Ancora Heart Inc. announced that the FDA granted breakthrough device designation to its transcatheter left ventricular implant to improve LV structure and function in patients with HF with reduced ejection fraction.
The implant (AccuCinch ventricular restoration system) is designed to reduce the size of the left ventricle, reduce ventricular wall stress and strengthen the heart wall in patients with HFrEF who remain symptomatic despite guideline-directed medical care, according to a company press release.
Breakthrough therapy designation is designed to expedite the development and review of