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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Occlutech noted that by placing its AFR device into the septum and making a restrictive atrial septal opening by maintaining the correct sizing of a created shunt, the intra cardiac pressure can be significantly reduced, thereby enhancing the heart’s function.
Depending on the indication, this shunt permits controlled flow of blood from the left atrium to the right atrium.
The resulting decompression of the left atrium could potentially reduce symptoms and improved exercise tolerance as well as the quality of life.
Occlutech Group Co-CEO Sabine Bois said: “It is an important milestone for us to have received this breakthrough designation.
“We are very proud and excited to work closely with the FDA in this opportunity to develop an important new therapy that positively impacts the lives’ of critically ill patients.”
At present, AFR is not approved in the US and is under clinical investigation for use in patients with PAH.