US FDA grants Breakthrough Device Designation to Occlutech’s Atrial Flow Regulator

The US Food and Drug Administration (FDA) has granted Occlutech a Breakthrough Device designation for Occlutech’s its implantable Atrial Flow Regulator (AFR) for pulmonary arterial hypertension (PAH).

Breakthrough Device designations are intended to fast-track the development, assessment and approval of new treatments for severe diseases. This can include a prioritised review to market approval.

AFR is a small implantable device which is made of Nitinol, a material used in implantable cardiac devices.

The device is implanted into the interatrial septum of the heart by routine, minimally invasive procedures.

PAH occurs due to changes in cells that cause damages of the lung arteries. This leads to the heart being forced to work harder to supply enough oxygen.

Gradually, the right ventricle enlarges to hold more blood and the added strain lead to heart failure.

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