AtriCure, Inc.'s Multifunctional Isolatorâ„¢ Transpolarâ„¢ Pen System Received USFDA 510(k) Clearance and New Isolator Transpolar Open Clamp Released

Filed in archive Diagnostics on July 30, 2006

AtriCure, Inc. has received USFDA 510(k) clearance for its Isolator Transpolar Pen System (Pen) for pacing, sensing, stimulating, and recording during the evaluation of cardiac arrhythmias in addition to its currently USFDA- cleared use for the ablation of cardiac tissues.

AtriCure's Pen is the only bipolar radiofrequency (RF) device that is cleared by the USFDA for this broad range of indications.

This multifunctional Pen has new capabilities that will allow physicians to identify potential trigger areas on the heart that could cause cardiac arrhythmias. Physicians may also be able to ablate these targeted cardiac triggers and directly evaluate the effectiveness of the ablation, using the same device.

On a separate occasion, the Company also announced the release of its new Isolator Transpolar open clamp featuring a design that improves the surgeon's access to key anatomical structures, simplifies the ablation procedure and provides superior tactile feedback to the user.

This new clamp currently has been cleared by the USFDA for the ablation of soft tissues in general, thoracic and other non-cardiac related surgical procedures.

The first case with the new Isolator Transpolar System was conducted on June 28, 2006 by Patrick M. McCarthy, M.D., Chief, Division of Cardiothoracic Surgery at Northwestern Memorial Hospital in Chicago, IL.

"My experiences with the new Isolator open clamp have been very encouraging. The new design makes the system easier to position around structures and the ablation lines are much more visible which assists in completing a successful ablation procedure," said Dr. McCarthy.

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