Brief Summary: Please review the Instructions for Use prior to using these devices for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.
The Therapy™ Cardiac Ablation System is indicated for mapping and for use with a compatible RF generator for: interruption of accessory atrioventricular (AV) conduction pathways associated with tachycardia; the treatment of AV nodal re-entrant tachycardia (AVNRT); or creation of complete AV nodal block in patients with a difficult to control ventricular response to an atrial arrhythmia.
In patients with active systemic infection. In patients with intracardiac mural thrombus, ventriculotomy or atriotomy within the preceding four weeks.
Catheter ablation procedures present the potential for significant x-ray exposure. The long-term risk of protracted fluoroscopy has not been established. Careful consideration must be given for the use of the device in prepubescent children and pregnant women. The long term risks of RF ablation lesions have not been established. Patients undergoing AV nodal modification or ablation of septal accessory pathways are at risk for inadvertent AV block.
Appropriate DIP pads should be used to minimize skin burns.
POTENTIAL ADVERSE EVENTS
Potential adverse events include, but are not limited to, cardiovascular and anesthesia-related complications, including complete heart block requiring pacemaker. Please refer to the Instructions for Use for a complete list.
Last Updated: January 02, 2019
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