Occlutech Announces FDA Breakthrough Device Designation for Atrial Flow Regulator in Pulmonary Arterial Hypertension

SCHAFFHAUSEN, Switzerland, Dec. 21, 2020 /PRNewswire/ -- Occlutech, a privately held company, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its first-in-class implantable Atrial Flow Regulator (AFR) for the treatment of pulmonary arterial hypertension (PAH).

Thousands of people in the United States and around the world suffer from pulmonary arterial hypertension (PAH), a condition caused by cellular changes that lead to damage in the pulmonary arteries. The heart’s workload increases as it strives to supply sufficient oxygen. Patients experience symptoms such as shortness of breath, dizziness, and fatigue. The severity of these symptoms is typically correlated with disease progression and significantly reduces quality of life. As the condition advances, the right ventricle enlarges to accommodate increased blood volume, and the resulting additional pressure gradually leads to heart failure. Placement of Occlutech’s Atrial Flow Regulator (AFR) device within the interatrial septum creates a restrictive atrial septal communication by maintaining an appropriately sized shunt, thereby substantially reducing intracardiac pressure and improving cardiac function.

The Breakthrough Medical Device Designation aims to accelerate the development, evaluation, and approval of new therapies for serious diseases, including priority review up to marketing authorization.

“Receiving this breakthrough designation is a significant milestone for us,” said Sabine Bois, Co-CEO of the Occlutech Group. “We are proud and delighted to work closely with the FDA to leverage this opportunity in developing an important new therapy that will positively impact the lives of critically ill patients.”

Occlutech is one of the leading companies in this field, with its main products including PFO occluders and ASD occluders utilizing state-of-the-art technology. Occlutech sells products for congenital and structural heart disease in more than 80 countries worldwide and maintains production and R&D facilities in Jena, Germany, and Istanbul, Turkey. Occlutech has developed numerous novel products and technologies to improve treatment for patients in these and related fields.

For more information about the company’s products, Occlutech AFR, or to inquire about participation in our patient registry, please visit the Occlutech website.www.occlutech.com, or throughAFR@occlutech.comContact us directly.

AFR has not yet been approved in the United States. Product availability is subject to local regulatory approval. The use of AFR in patients with pulmonary arterial hypertension is currently in the clinical research phase, and its use in these patients is restricted by applicable national laws.