First Human Case Successfully Performed Using AtriCure’s Cryo1 System

AtriCure, Inc. (Nasdaq: ATRC), a medical device company and a leader in surgical cardiac ablation, today 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.