Occlutech’s Atrial Flow Regulator Receives FDA Breakthrough Device Designation for Heart Failure

January 19, 2021—Switzerland-based Occlutech AG announced that the FDA has granted Breakthrough Device designation for the company’s implantable atrial flow regulator (AFR) for patients with heart failure with preserved ejection fraction or heart failure with reduced ejection fraction who, despite optimal medical therapy, experience worsening symptoms.

According to the company, the AFR maintains an interatrial shunt with a predetermined diameter, which allows for controlled blood flow from the left to the right atrium, enabling the left atrium to decompress and lower left atrial pressure.

FDA Breakthrough Device designations aim to accelerate the development, assessment, and approval of new treatments in severe diseases, including a prioritized review all the way through market approval, noted the company.

In September 2019, Occlutech announced European CE Mark approval for the AFR device to treat heart failure. The device is under clinical investigation for use in patients with pulmonary arterial hypertension, and use in these patients is limited by applicable national laws.