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View of the Cardioblate™ CryoFlex™ sugical ablation console on a transparent background

Indications, Safety, and WarningsIndications for use The 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.Contraindications The CryoFlex™ surgical ablation probe is not designed for use inside a beating heart.Adverse events or complications Potential 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.See the instructions for use which accompany each product for detailed information regarding the indications, contraindications, warnings, precautions, and potential complications/adverse events.Important safety informationPotential adverse events 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.Caution: Swedish law restricts this device to be ordered by, and sold to, a physician or medical institution only.UC202409948 EN

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