CardioFocus announced that it has been awarded European CE Mark approval for its proprietary endoscopic ablation system. The transvenous device combines real-time, full color, endoscopic visualization and guidance with the delivery of therapeutic light energy to perform pulmonary vein isolation for the treatment of atrial fibrillation.

The technology has also received U.S. investigational device exemption (IDE) approval for clinical investigation in a randomized, multi-center study, currently underway and enrolling patients at over a dozen medical centers in the U.S., according to the Marlborough, Mass.-based company.