The regulatory nod, earned last week, allows the Marlborough, Massachusetts-based company to bring the newest PFA catheter in its electrophysiology portfolio to the European market. Farapoint treats right atrial flutter (AFL), ablating the cavotricuspid isthmus (CTI) area of the heart.

Boston Scientific says CE mark represents a new cardiac arrhythmia indication for its Farapulse PFA platform, now extending to AFL. Farapulse, a PFA system originally developed to treat AFib, received a much-anticipated FDA approval for that indication last year.