AtriCure wins CE Mark for AtriClip Pro2 LAA occluder

AtriCure (NSDQ:ATRC) said today it won CE Mark approval in the European Union for the AtriClip Pro2 left atrial appendage exclusion system designed for minimally-invasive LAA occlusion procedures.

The AtriClip Pro2 system is designed with an ambidextrous locking and trigger-style clip closing mechanism, the West Chester, Ohio-based company said, as well as handle-based active articulation levers and a hoopless end effector.

“We are excited to bring the AtriClip PRO2 device to the European market. The US launch has been well received by our customers and we’re looking forward to the continued growth of the AtriClip franchise,” CEO Michael Carrel said in a press release.

In April, AtriCure said it won FDA 510(k) clearance for its AtriClip Pro2 and launched the device in the U.S.

In February, the company said it’s launching a clinical trial of its AtriClip left atrial appendage closure device, aiming to show whether the device reduces the incidence of post-operative atrial fibrillation after cardiac surgery to repair a structural heart defect.

AtriCure said the 1st patient in the 1-year Atlas trial was enrolled at PinnacleHealth Hospitals in Harrisburg, Pa. The study, which is slated to enroll up to 2,000 patients with a high risk of developing POAF, is designed to compare treatment with AtriClip in conjunction with a heart defect repair procedure to patients who undergo heart defect repair alone. It’s also designed to evaluate healthcare resource utilization between the 2 groups, AtriCure said.

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