Occlutech's Atrial Flow Regulator for Heart Failure Receives FDA Breakthrough Device Designation
Occlutech's Atrial Flow Regulator for Heart Failure Receives FDA Breakthrough Device Designation The Occlutech implantable Atrial Flow Regulator (AFR) maintains an interatrial shunt with a predetermined diameter allowing for controlled blood flow from the left to the right atrium enabling the left atrium to decompress and lower left atrial pressure. This reduced left atrial pressure reduces heart failure symptoms and improves exercise tolerance. January, 27, 2021 — The U.S. Food and Drug Administration (FDA) has granted Occlutech a Breakthrough Device designation for its first-in-class,...