Product image of the Cardioblate™ BP2 bipolar clamp shown vertically from the side

60832

Cardioblate™ BP2 IRF Bipolar Clamp

The Cardioblate™ BP2 device uses irrigated bipolar radiofrequency (RF) energy to provide surgeons with a means to ablate cardiac tissue in surgical procedures.

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Indications, Safety, and WarningsIndications for useThe Cardioblate™ BP2 surgical ablation device is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.ContraindicationsThe Cardioblate™ BP2 surgical ablation device should not be used for:

Patients who have active endocarditis at the time of surgery

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

Potential complicationsPossible 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

Thrombus formation

Important safety informationPossible 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.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.UC202410576 EN

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60832 Cardioblate™ BP2 IRF Bipolar Clamp

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60832

Cardioblate™ BP2 IRF Bipolar Clamp