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. The
success of this procedure depends on many factors, including your physical condition and your body’s
ability to tolerate the procedure. Use care in the selection of your doctors and hospital, based on their
skill and experience.
Catheters are approved for drug refractory recurrent symptomatic paroxysmal atrial fibrillation,
when used with CARTO® 3
Systems (excluding NAVISTAR® RMT THERMOCOOL®Catheter).
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.