AtriCure wins FDA 510(k) for AtriClip Pro2 LAA device

AtriCure (NSDQ:ATRC) said today it won 510(k) clearance for its AtriClip Pro2 left atrial appendage exclusion system designed to occlude the LAA during minimally-invasive surgical 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 receive FDA clearance for the AtriClip PRO2 device. The AtriClip franchise is the fastest growing part of our business, and we are committed to continued innovation to help our customers meet the needs of their patients. The AtriClip PRO2 system has several advancements that make it easier to use in MIS procedures,” CEO Michael Carrel said in a prepared release.

“The AtriClip PRO2 system provides easier placement of the proven AtriClip LAA occlusion technology. The new deployment system facilitates less invasive treatment of the LAA, including right chest approaches in conjunction with valve replacement and cardiac ablation procedures,” Dr. J. Smith, MD of Cincinnati’s TriHealth Heart Institute said in prepared remarks.

Earlier this month, AtriCure said it won FDA 510(k) clearance for its  CryoForm cryoablation probe designed for use in cardiac ablation procedures, such as atrial fibrillation.

The CryoForm is designed with the ability to remove heat and actively defrost, which allows the operator to safely detach the device while maintaining internal tissue’s frozen state, the company said.

The company said the probe allows for increased flexibility and easier manipulation to allow for better conformation in challenging anatomies.

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