Medtronic

Important Safety Information
Cardiac lesions that work.
Cardioblate® Delivers Confidence Create cardiac lesions that achieve reliable, reproducible conduction block with the Cardioblate® Irrigated RF Surgical Ablation System.1 Powered by the 68000 Generator, our irrigated bipolar and monopolar surgical ablation devices are proven to achieve consistent conduction block.1 Our MAPS and Detect® devices provide the verification you need to confirm conduction block in both your concomitant and stand-alone cases.2,3 The Navigator® Tissue Dissector provides required access to the ablation site during stand-alone ablation.

Important Risk Information

Surgical Ablation Devices: 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); and acute ischemic myocardial event.

Cardioblate Navigator Tissue Dissector: Using excessive force when articulating may damage the distal links and/or cause unintended tissue damage.

Cardioblate 68000 Generator: To avoid the risk of electrical shock and/or burns to the patient, do not touch the patient while touching the outer housing or connections on the Cardioblate generator. Do not allow the patient to come into contact with the grounded metal surfaces during RF energy delivery.

Cardioblate Navigator Tissue Dissector: Using excessive force when articulating may damage the distal links and/or cause intended (replace intended with unintended) tissue damage.