AtriCure's Coolrail(TM) Linear Ablation Pen Receives FDA 510(k) Clearance

Main Category: Cardiovascular / Cardiology
Also Included In: Medical Devices / Diagnostics;  Regulatory Affairs / Drug Approvals
Article Date: 19 Mar 2008 - 0:00 PDT

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AtriCure, Inc. (Nasdaq: ATRC), a medical device company and leader in cardiac surgical ablation systems, announced that its Coolrail(TM) linear ablation pen received 510(k) clearance from the FDA for the ablation of cardiac tissue. Additionally, the first patient was successfully treated using the AtriCure Coolrail(TM) Linear Ablation Pen. The Coolrail(TM) linear ablation pen and ORLab(TM) system were used during a procedure performed by Dr. James R. Edgerton, a prominent cardiac surgeon from the Cardiopulmonary Research Science and Technology Institute of Dallas, Texas. The Coolrail(TM) 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(TM) system is a mapping, recording and stimulating system which 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 protocol used for mapping with the ORLab(TM) system was developed by Dr. Warren M. Jackman, a prominent electrophysiologist.

Dr. James R. Edgerton commented, "We are encouraged by the results of the combined use of AtriCure's Coolrail(TM) pen and ORLab(TM) 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." Dr. Warren Jackman commented, "Based on our investigation and collaboration with Dr. Edgerton, I believe that AtriCure's minimally invasive ablation platform has the potential to become the standard of care for chronic atrial fibrillation patients."

"We believe that the Coolrail(TM) pen combined with the ORLab(TM) system will provide our Company with new market opportunities and broaden the adoption of our minimally invasive products. The release of these new products substantially strengthens our business and positions AtriCure to pursue atrial fibrillation indications from the FDA for our minimally invasive sole-therapy products," said David J. Drachman, President and Chief Executive Officer. "During 2008 we plan on initiating enrollment in our FDA regulated clinical trial, RESTORE SR-IIB. This prospective, non-randomized, feasibility trial will enroll 25 patients at five leading U.S. medical centers. The results of RESTORE SR-IIB will be used to design and support U.S. pivotal trials of our minimally invasive sole-therapy ablation system for the treatment of atrial fibrillation."

About AtriCure, Inc.

AtriCure, Inc. is a medical device company and a leader in developing, manufacturing and selling innovative cardiac surgical ablation systems designed to create precise lesions, or scars, in cardiac, or heart, tissue. Medical journals have described the adoption by leading cardiothoracic surgeons of the AtriCure Isolator(R) bipolar ablation system as a treatment alternative during open-heart surgical procedures to create lesions in cardiac tissue to block the abnormal electrical impulses that cause atrial fibrillation, or AF, a rapid, irregular quivering of the upper chambers of the heart. Additionally, medical journals and leading cardiothoracic surgeons have described the AtriCure Isolator(R) system as a promising treatment alternative for patients who may be candidates for sole-therapy minimally invasive procedures. AF affects more than 5.5 million people worldwide and predisposes them to a five-fold increased risk of stroke.

The FDA has cleared the AtriCure Isolator(R) bipolar ablation system, including the new Isolator Synergy(TM) ablation clamps and multifunctional and linear ablation pens, for the ablation, or destruction, of cardiac tissue during surgical procedures. Additionally, the FDA has cleared AtriCure's multifunctional pen for temporary pacing, sensing, stimulating and recording during the evaluation of cardiac arrhythmias. To date, the FDA has not cleared or approved AtriCure's products for the treatment of AF. AtriCure's left atrial appendage clip system has not been approved for commercial use. It is currently being used in clinical evaluations in Europe.

Forward Looking Statements

This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward- looking statements include statements that address activities, events or developments that AtriCure expects, believes or anticipates will or may occur in the future, such as earnings estimates, other predictions of financial performance, launches by AtriCure of new products and market acceptance of AtriCure's products. Forward-looking statements are based on AtriCure's experience and perception of current conditions, trends, expected future developments and other factors it believes are appropriate under the circumstances and are subject to numerous risks and uncertainties, many of which are beyond AtriCure's control. These risks and uncertainties include the rate and degree of market acceptance of AtriCure's products, AtriCure's ability to develop and market new and enhanced products, the timing of and ability to obtain and maintain regulatory clearances and approvals for its products, the timing of and ability to obtain reimbursement of procedures utilizing AtriCure's products, competition from existing and new products and procedures or AtriCure's ability to effectively react to other risks and uncertainties described from time to time in AtriCure's SEC filings, such as fluctuation of quarterly financial results, reliance on third party manufacturers and suppliers, litigation (including the purported class action lawsuit) or other proceedings, government regulation and stock price volatility. AtriCure does not guarantee any forward-looking statement, and actual results may differ materially from those projected. AtriCure undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

AtriCure, Inc.
http://www.atricure.com