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AtriCure’s cryoablation system receives US FDA clearance

Source reference: http://www.mtbeurope.info/news/2009/904019.htm

AtriCure, Inc. (Nasdaq: ATRC), has announced that its new disposable cryoablation system, Cryo1, received 510(k) clearance from the US 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 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 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.” 

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