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Occlutech announces Completion of Patient Enrolment in Pilot Study of Atrial Flow Regulator (AFR) in Patients with Heart Failure
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Occlutech announces Completion of Patient Enrolment in Pilot Study of Atrial Flow Regulator (AFR) in Patients with Heart Failure
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Occlutech announces Completion of Patient Enrolment in Pilot Study of Atrial Flow Regulator (AFR) in Patients with Heart Failure
prnewswire.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from prnewswire.com Daily Mail and Mail on Sunday newspapers.
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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 lifetime risk of HF increases with age, with over 50% of hospitalizations of persons aged 65 or older attributable to HF. Heart Failure Symptoms include fatigue, palpitations, and exertional dyspnea. HF may result from disorders of the pericardium, myocardium, endocardium, heart valves, great vessels, or specific metabolic abnormalities. These disorders affect the heart s structure or function, whic
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 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