AtriCure gets 510(k) clearance for cardiac arrhythmia pen system

By Elaine Rigoli

Tampa, Fla., July 20 - AtriCure, Inc. has received Food and Drug Administration 510(k) clearance for its Isolator Transpolar Pen system for pacing, sensing, stimulating and recording during the evaluation of cardiac arrhythmias in addition to its currently FDA-cleared use for the ablation of cardiac tissues.

The company said the AtriCure Pen is the only bipolar radiofrequency device that is cleared for this broad range of indications.

The new capabilities of this multifunctional Pen allow physicians to identify potential trigger areas on the heart that could cause cardiac arrhythmias, according to a news release.

Separately, the company announced the release of its new Isolator Transpolar open clamp.

The clamp currently has clearance from the FDA for the ablation of soft tissues in general, thoracic and other non-cardiac related surgical procedures.

Located in West Chester, Ohio, AtriCure is a medical-device company focused on developing surgical devices to create precise lesions, or scars, in soft and cardiac tissues.

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