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/PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using...
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,...
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...
Press release content from PR Newswire. The AP news staff was not involved in its creation. Occlutech’s Atrial Flow Regulator (AFR) Receives U.S. FDA Breakthrough Device Designation December 18, 2020 GMT 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 resul...
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 h...