FDA gives 510(k) approval for CryoFORM cryoablation probe for cardiac arrhythmias- AtriCure

AtriCure has received FDA 510(k) clearance for the CryoFORM cryoablation probe, which offers increased probe flexibility to adapt to a variety of surgical ablation procedures to treat cardiac arrhythmias. The probe was previously launched in October 2015 in the European market under a CE mark.

The cryoICE cryoFORM cryoablation probe is indicated for use in the cryosurgical treatment of cardiac arrhythmias by freezing target tissues, creating an inflammatory response (cryonecrosis) that blocks the electrical conduction pathway.