Occlutech s Atrial Flow Regulator (AFR) Receives U.S. FDA Breakthrough Device Designation
SCHAFFHAUSEN, Switzerland, Dec. 18, 2020 /PRNewswire/ Occlutech, a privately-held company, announced today that the US Food and Drug Administration (FDA) has granted the company a Breakthrough Device designation for its first-in-class, implantable Atrial Flow Regulator (AFR) for Pulmonary Arterial Hypertension (PAH).
PAH affects hundreds of thousands in the U.S. and globally and is resulting from changes in cells that causes damages of the lung arteries. Consequentially, the heart is forced to work harder to supply enough oxygen. The patient experiences symptoms such as shortness of breath, dizziness and fatigue. The severity of these symptoms usually correlates with progression of the disease and significantly reduced quality of life. Over time, the right ventricle enlarges to hold more blood and the additional strain gradually causes the heart to fail. By placing the Occlutech AFR device
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