Caution: US law restricts this device to sale by or on the order of a physician. Important information: Prior to use, refer to the instructions for use supplied with this device for indications, contraindications, side effects, warnings and precautions.
The NAVISTAR® THERMOCOOL®, EZ STEER® THERMOCOOL® NAV, THERMOCOOL® SF NAV, and THERMOCOOL SMARTTOUCH® Catheters are FDA approved for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with compatible three-dimensional electroanatomic mapping systems. Catheter ablation for AF may not be an option for you if you have any of the following conditions: certain recent heart surgery; prosthetic valves; active systemic infection; certain cancers; intracardiac thrombus, or an interatrial baffle or patch. Consult your physician to find out if catheter ablation is right for you.
As with any medical treatment, individual results may vary. Only a cardiologist or electrophysiologist can determine whether ablation is an appropriate course of treatment. There are potential risks including bleeding, swelling or bruising at the catheter insertion site, and infection. More serious complications are rare, which can include damage to the heart or blood vessels; blood clots (which may lead to stroke); heart attack, or death. These risks need to be discussed with your doctor and recovery takes time.
THERMOCOOL® Navigation Catheters are indicated for the treatment of recurrent drug/device refractory sustained monomorphic ventricular tachycardia (VT) due to prior myocardial infarction (MI) in adults.