Anasayfa Ürünler OCCLUTECH Occlutech Atrial Flow Regulator (AFR)
A cardiac implant designed to address the unmet medical needs of patients suffering from heart failure (HF) despite optimal medical therapy.
Implanted on the interatrial septum of the heart using routine, minimally invasive procedures.
Intended to permanently maintain the interatrial communication (shunt) created by Balloon Atrial Septostomy (BAS). This shunt allows for the controlled flow of blood from the left,- to the right atrium.
The Occlutech Atrial Flow Regulator (AFR) is a cardiac implant designed to address the unmet needs of patient suffering from heart failure (HF), despite optimal medical therapy.
The small implantable device is made of Nitinol, a material used widely in implantable cardiac devices, and placed on the interatrial septum of the heart using routine, minimally invasive procedures.
Occlutech has over 16 years of experience in making Nitinol-based cardiac implants and we developed the AFR with the aim to provide an innovative and minimally invasive (nonsurgical), treatment alternative to address the unmet medical needs of HF patients.
Once implanted, the Occlutech Atrial Flow Regulator is intended to permanently maintain the interatrial communication created by Balloon Atrial Septostomy (BAS). Per the HF indication, 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.
The Occlutech Atrial Flow Regulator has not received FDA Premarket Approval or been licensed by Health Canada.