Heart products supplier Occlutech International reported on Friday the receipt of the US Food and Drug Administration (FDA) Breakthrough Device designation to accelerate the development, assessment and approval for its first-in-class, implantable Atrial Flow Regulator (AFR) for Pulmonary Arterial Hypertension (PAH), which causes damages of the lung arteries.

This causes the heart to be 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 to hold more blood and the additional strain gradually causes the heart to fail.

The company's AFR device is placed into the septum to create a restrictive atrial septal opening by maintaining the correct sizing of a created shunt, the intra cardiac pressure is substantially reduced, thereby improving the heart's function.

According to the company, the AFR is under clinical investigation for use in patients with pulmonary arterial hypertension and use in these patients is limited by applicable national laws. The product availability is subject to local regulatory clearance.