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news.AtriCure, a medical device company, has received 510(k) clearance from the FDA for its Cryo1, a new disposable cryoablation system, for the cryosurgical treatment of cardiac arrhythmias.
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Additionally, the first patient was successfully treated using the Cryo1 system by Niv Ad, the chief of cardiac surgery at Inova Fairfax Hospital Department of Cardiovascular and Thoracic Surgery in Falls Church, Virginia, the company said.
According to AtriCure, 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.
David Drachman, president and CEO of AtriCure, said: “The commercial release of our Cryo1 system further positions AtriCure as the leader in the surgical markets for cardiac ablation products. We are excited to offer this new technology solution which we believe will lead to market share gains and demonstrates our continued commitment to developing innovative technologies.”