New Cryoablation System from AtriCure Receives FDA Clearance


March 30, 2009

March 30, 2009 - AtriCure Inc.’s new disposable cryoablation system, Cryo1, has received 510(k) clearance from the FDA for the cryosurgical treatment of cardiac arrhythmias.

Dr. Niv Ad, M.D., chief of cardiac surgery at Inova Fairfax Hospital Department of Cardiovascular and Thoracic Surgery in Falls Church, VA. successfully treated the first patient using the Cryol system. Using the AtriCure Frigitronics CCS-200 console and the Cryo1 linear disposable ablation probe, Dr. Ad, an internationally recognized thought leader in the field of cardiac surgery and the surgical treatment of cardiac arrhythmias, performed a minimally invasive, sole therapy cardiac ablation procedure.

The Cryo1 system offers a long, malleable yet rigid design to achieve consistent contact, superior thermal dynamics and an active defrost mode that reportedly increases ease of use. The AtriCure Frigitronics CCS-200 console supports both the Cryo1 disposable probe and the company’s line of reusable cryoablation probes.

“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.”

For more information: