The Atrial Flow Regulator (AFR) is a cardiac implant designed to address the unmet medical needs of patients suffering from heart failure (HF) despite optimal medical therapy.
The Company has over 15 years of experience in the making and use of Nitinol-based cardiac implants and has developed the AFR to provide an innovative, minimally invasive (non-surgical) treatment alternative to address the significant unmet medical needs in HF patients.
The AFR is a small implantable device made of Nitinol, a material used widely in implantable cardiac devices. The AFR device is implanted into the interatrial septum of the heart using routine, minimally invasive procedures.
Once implanted, the AFR is intended to maintain a permanent interatrial communication with a predetermined diameter (shunt). Depending on the indication (HF or PH), This shunt allows for the controlled flow of blood from the left atrium to the right atrium. The resulting decompression of the left atrium is expected to lead to reduced symptoms and to improved exercise tolerance and quality of life.
The Occlutech Atrial Flow Regulator (AFR) has not received FDA Premarket Approval, or been licensed by Health Canada.