Occlutech AFR Heart Failure Device Obtains CE Mark Approval

September 6, 2019—Occlutech AG announced that its atrial flow regulator (AFR), a next-generation intra-atrial shunt device, has obtained European CE Mark approval. The Occlutech AFR is intended to treat heart failure symptoms by decompressing abnormal intra-atrial pressure.

According to the company, the device is placed in the septum between the left atrium and right atrium in a minimally invasive procedure. This creates a restrictive atrial septal opening by maintaining the correct sizing of a created shunt. The intra-cardiac pressure is substantially reduced, thereby improving the heart's function.

The device is manufactured in different sizes, which allows for unique patient-oriented and individualized treatment, stated Occlutech.