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View of the Cardioblate™ Cryoflex™ surgical ablation probe on a transparent background

Indications, Safety, and WarningsIndications for useThe Cardioblate™ CryoFlex™ surgical ablation system is intended for minimally invasive cardiac surgical procedures, including the treatment of cardiac arrhythmias. The Cardioblate™ CryoFlex™ 7-cm, 10-cm, and 10-S probes plus the CryoFlex™ clamp and CryoFlex™ surgical ablation console freeze target tissue and block the electrical conduction pathways by creating an inflammatory response and cryonecrosis.ContraindicationsThe CryoFlex™ surgical ablation probe is not designed for use inside a beating heart.Adverse events and complicationsPotential adverse effects with this device are similar to other cardiac surgery procedures and may include the following: bleeding; re-operation; extension of extracorporeal bypass; heart rhythm disturbances (atrial and/or ventricular); pericardial effusion; pericarditis; cardiac tamponade; pleural effusion; mediastinitis; conduction disturbances (SA/AV node); acute ischemic myocardial event; thrombus formation; low cardiac output; stroke; renal, gastrointestinal or respiratory complications; sepsis; adjacent structural damage; and death.Cryoablation involving coronary vessels has been associated with subsequent clinically significant arterial stenosis. It is unknown whether cryoablation with the CryoFlex™ surgical ablation probe will have such an effect, but as in all such procedures, care should be taken to minimize unnecessary contact with coronary vessels during cryoablation.Caution: Federal law (United States) restricts this device to sale by or on the order of a physician. For a complete listing of all indications, contraindications, precautions and warnings, please refer to the instructions for use which accompany each product.UC202410023 EN

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