Occlutech's Atrial Flow Regulator (AFR) Receives U.S. FDA Breakthrough Device Designation for Heart Failure (HF)
Share this article Share this article SCHAFFHAUSEN, Switzerland, Jan. 19, 2021 /PRNewswire/ -- Occlutech, a privately-held company, announced today that the U.S Food and Drug Administration (FDA) has granted the Company a Breakthrough Device designation for its first-in-class, implantable Atrial Flow Regulator (AFR) for heart failure (HF) patients with preserved (HFpEF) or reduced (HFrEF) ejection fraction. Heart failure (HF) is a serious condition characterized by the heart's inability to pump an adequate blood supply to the body. Worldwide, HF affects over 30 million people, and the lifeti...
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