AtriCure’s Coolrail Linear Ablation Pen Gets FDA Go Ahead


March 18, 2008

March 18, 2008 – The FDA gave AtriCure’s Coolrail linear ablation pen 510(k) clearance for the ablation of cardiac tissue, which can be used for patients with persistent and long-standing persistent atrial fibrillation, as the company expands its line of minimally invasive products.

The Coolrail linear ablation pen is designed to facilitate the creation of an expanded cardiac ablation lesion set during a minimally invasive off-pump procedure. The ORLab system is a mapping, recording and stimulating system, which reportedly enables electrophysiologists and surgeons to confirm, in the operating room, that the cardiac ablation lines being created are forming electrical barriers or lines of conduction block.

The first patient was successfully treated using the AtriCure Coolrail Linear Ablation Pen. The Coolrail linear ablation pen and ORLab system were used during a procedure performed by James R. Edgerton, M.D., a cardiac surgeon from the Cardiopulmonary Research Science and Technology Institute of Dallas, TX.

“We are encouraged by the results of the combined use of AtriCure's Coolrail pen and ORLab system to more effectively perform an expanded cardiac ablation procedure. Based on our previous research, we anticipate that our investigation of these new products will demonstrate improved results in patients with persistent and long- standing persistent atrial fibrillation,” said Dr. Edgerton.

The company will initiate enrollment this year in an FDA regulated clinical trial, RESTORE SR-IIB. The prospective, non-randomized, feasibility trial will enroll 25 patients at five U.S. medical centers. The results of RESTORE SR-IIB will be used to design and support U.S. pivotal trials of Atricure’s minimally invasive sole-therapy ablation system for the treatment of atrial fibrillation.

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