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<h2>Indications, Safety, and Warnings</h2> <h3>Indications for use</h3> <p>The Cardioblate™ LP surgical ablation device is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.</p> <h3>Contraindications</h3> <p>The Cardioblate™ LP surgical ablation device should not be used for:</p> <ul> <li>Patients that have active endocarditis at the time of surgery</li> <li>Ablation in a pool of blood (e.g., through a purse string suture on a beating heart); effects of this type of ablation are unknown.</li> </ul> <h3>Potential complications</h3> <p>Possible complications related to the ablation of cardiac tissue in combination with open heart surgery are:</p> <ul> <li>Tissue perforation</li> <li>Extension of extracorporeal bypass</li> <li>Perioperative heart rhythm disturbances (atrial and/or ventricular)</li> <li>Postoperative embolic complications</li> <li>Pericardial effusion or tamponade</li> <li>Injury to the great vessels</li> <li>Valve leaflet damage</li> <li>Conductions disturbances (SA/AV node)</li> <li>Acute ischemic myocardial event</li> <li>Thrombus formation</li> </ul> <h3>Important safety information</h3> <p>Possible complications related to the ablation of cardiac tissue in combination with open heart surgery are tissue perforation, extension of extracorporeal bypass, perioperative heart rhythm disturbances (atrial and/or ventricular), postoperative embolic complications, pericardial effusion or tamponade, injury to the great vessels, valve leaflet damage, conductions disturbances (SA/AV node), acute ischemic myocardial event and thrombus formation.</p> <p><b>Caution:</b> 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.</p> <p>UC202409825 EN</p>

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