Occlutech said today that its eponymous atrial flow regulator device received CE Mark approval in the European market.
The Occlutech AFR is an intra-atrial shunt designed be placed between the left and right atria to treat heart failure symptoms by decompressing abnormal intra-atrial pressure.
In a release, the Germany-based company said malfunction of the left heart leads to pulmonary congestion and shortness of breath, a common symptom of heart failure. The Occlutech AFR, when placed into the septum of the heart, is designed to create a restrictive atrial septal opening, reducing intra-cardiac pressure and improving the heart’s function.
“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.” Occlutech co-CEO Sabine Bois said in prepared remarks. “The Occlutech AFR with its efficacy, versatility, convenience and safety has true potential to revolutionize the way heart failure patients are treated.”
