Atrial Flow Regulator Helps Manage Heart Failure

A next generation implantable shunt device treats heart failure (HF) or pulmonary hypertension (PH) symptoms by decompressing abnormal intra-atrial pressure.

The Occlutech (Schaffhausen, Switzerland) atrial flow regulator (AFR) HF Device is a double-disc shaped shunt placed in the septum between the left and right atriums, via a minimally invasive balloon atrial septostomy (BAS) procedure, in order to create a restrictive atrial septal opening. Made of nickel-titanium (Nitinol), the AFR is intended to maintain a permanent interatrial fenestration of varying diameters (6-10 mm) secured by two discs. Depending on the indication (HF or PH), the shunt allows for the controlled flow of blood between the atria of the heart.

By maintaining the predetermined diameter shunt open in the intra-atrial septum, cardiac pressure is substantially reduced, resulting in a decompression of the heart chambers which leads to reduced HF and PH symptoms, and as a result to an improved exercise tolerance and to better quality of life (QOL). The AFR HF Device is manufactured in different sizes, allowing for a unique, patient-oriented, and individualized treatment. The Occlutech AFR Device has received the European Union CE mark of approval.

“With CE mark approval of the Occlutech AFR we are taking another big step towards becoming a multi-franchise congenital and structural heart disease therapy provider,” said Sabine Bois, Co-CEO of Occlutech. “The Occlutech AFR with its efficacy, versatility, convenience, and safety has true potential to revolutionize the way heart failure patients are treated.”

Unlike systemic blood pressure, pulmonary blood pressure reflects the pressure the heart exerts to pump blood from the right ventricle, which receives the oxygen-depleted blood, into the pulmonary arteries, and on to the left atrium. Normal pulmonary artery pressure is 8-20 mm Hg at rest (much lower than systemic blood pressure); if the pressure in the pulmonary artery is greater than 25 mm Hg at rest or 30 mmHg during physical activity, it is abnormally high and is called PH.

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