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, which results in reduced cardiac output and/or elevated intracardiac pressures at rest or during exercise. When HF is left untreated, symptoms gradually worsen, resulting in increased morbidity, clinically driven hospitalizations, and higher mortality.

The AFR is for use in patients with Heart Failure with Preserved Ejection Fraction (HFpEF) or Reduced Ejection Fraction (HFrEF) and who, despite optimal medical therapy, experience worsening symptoms. The 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. Reduced left atrial pressure has been shown to reduce heart failure symptoms and improve exercise tolerance.

Breakthrough Device Designations aim to accelerate the development, assessment, and approval of new treatments in severe diseases, including a prioritized review all the way through market approval.

"It is an important milestone for us to have received this second breakthrough designation for our AFR device." says Sabine Bois, CEO Occlutech Group. "After receiving the first Breakthrough Device designation for pulmonary arterial hypertension (PAH) in December 2020, the heart failure (HF) indication addresses a substantial market with rapid growth and only limited options for the treatment for critically ill patients. We are looking forward to developing an important new therapy and working closely with the FDA on both indications."

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