AtriCure's Cryoablation System, Cryo1™, Receives FDA 510(k) Clearance

Main Category: Cardiovascular / Cardiology
Also Included In: Regulatory Affairs / Drug Approvals;  Medical Devices / Diagnostics
Article Date: 30 Mar 2009 - 2:00 PDT

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AtriCure, Inc. (Nasdaq: ATRC), a medical device company and a leader in surgical cardiac ablation, announced that its new innovative disposable cryoablation system, Cryo1, received 510(k) clearance from the Food and Drug Administration, or FDA, for the cryosurgical treatment of cardiac arrhythmias. Additionally, the first patient was successfully treated using the Cryo1 system by Dr. Niv Ad, the Chief of Cardiac Surgery at Inova Fairfax Hospital Department of Cardiovascular and Thoracic Surgery in Falls Church, Virginia. Dr. Ad, an internationally recognized thought leader in the field of cardiac surgery and the surgical treatment of cardiac arrhythmias, successfully used the AtriCure Frigitronics CCS-200 console and the Cryo1 linear disposable ablation probe to perform a minimally invasive, sole therapy cardiac ablation procedure.

The Cryo1 system offers several important benefits, including a long, malleable yet rigid design to achieve consistent contact, superior thermal dynamics and an active defrost mode which increases ease of use. In addition, the AtriCure Frigitronics CCS-200 console supports both our Cryo1 disposable probe and our well-established line of reusable cryoablation probes. The Frigitronics CCS-200 console and reusable probes have a strong market presence and a documented track record of safety and efficacy resulting from more than thirty years of use in cardiac arrhythmia procedures.

"The design and capabilities of the Cryo1 probe build on the high performance of the AtriCure Frigitronics platform. During this initial case we took advantage of the system's unique capability to use reusable and disposable cryothermy ablation probes during the same procedure," said Dr. Ad. "The active defrost function and the probe rigidity made the Cryo1 probe easy to use. This is a promising new technology and we look forward to further use and evaluation of the system."

"The commercial release of our Cryo1 system further positions AtriCure as the leader in the surgical markets for cardiac ablation products. AtriCure is now the only cardiac surgical ablation company marketing a series of cryothermy and bipolar radiofrequency ablation systems combined with an innovative portfolio of enabling tools and mapping products," said David J. Drachman, President and Chief Executive Officer. "We are excited to offer this new innovative technology solution which we believe will lead to market share gains and demonstrates our continued commitment to developing innovative technologies."

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® 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® 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® system, including its Isolator SynergyTM ablation clamps, and AtriCure's multifunctional pen and CoolrailTM linear ablation device, 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.

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.

Source
AtriCure, Inc.

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