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In the US, THERMOCOOL® Navigation Catheters are indicated for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with CARTO® 3 Systems (excluding NAVISTAR® RMT THERMOCOOL® Catheter).

The THERMOCOOL SMARTOUCH® SF Catheter is indicated for drug refractory recurrent symptomatic persistent atrial fibrillation (AF) (continuous AF > 7 days but < 1 year), refractory or intolerant to at least 1 Class I or III AAD, when used with the CARTO® 3 System.

In the US, THERMOCOOL® Non-Navigational Catheters are indicated for the treatment of Type I Atrial Flutter in patients 18 years of age or older.

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.

In the US, 4mm Catheters (NAVISTAR® Catheter, CELSIUS® Catheter, EZ STEER® Catheter (NAV and Non-NAV)) have a “General Indication” for creation of endocardial lesions in patients 4 years of age and older.  This “General Indication” includes treatment of Ventricular Tachycardia.

Always verify catheter tip location using fluoroscopy or IC signals and consult the CARTO® 3 System User Guide regarding recommendations for fluoroscopy use. Pellegrino, P.L., Brunetti, N.D., Gravina, D., Sacchetta, D., De Sanctis, V., Panigada, S., Di Biase, L., Di Biase, M., and Mantica, M. (2013). Nonfluoroscopic mapping reduces radiation exposure in ablation of atrial fibrillation. Journal of cardiovascular medicine 14, 528-533. Earley, M.J., Showkathali, R., Alzetani, M., Kistler, P.M., Gupta, D., Abrams, D.J., Horrocks, J.A., Harris, S.J., Sporton, S.C., and Schilling, R.J. (2006). Radiofrequency ablation of arrhythmias guided by non-fluoroscopic catheter location: a prospective randomized trial. Eur Heart J 27, 1223-1229

The CARTO VISITAG® Module provides access to data collected during the application of RF energy. The data does not indicate the effectiveness of RF energy application. CARTO VISITAG® Module settings are user defined based on the user’s clinical experience and medical judgment. Biosense Webster, Inc. does not recommend any settings for the CARTO VISITAG® Module.

The CARTO VISITAG® Module provides access to data collected during the application of RF energy. The data does not indicate the effectiveness of RF energy application. Do not use the Tag Index values generated from the VISITAG SURPOINT® EPU to guide RF energy delivery. Equivalent Tag Index values do not represent equivalent RF lesion size. The clinical utility of the Tag Index value has not been established. The Tag Index values should not be used to replace standard handling precautions or other clinically accepted endpoints for RF applications such as reduction of IC signals, impedance drop, and duration. All safety considerations, cautions, and warnings that apply to the general use of the CARTO® 3 System also apply while using this module. Users should follow the instructions for use of the compatible ablation catheters (i.e. THERMOCOOL SMARTTOUCH® Catheter and THERMOCOOL SMARTTOUCH® SF Catheter) to select ablation settings for an ablation procedure.

Use of the PENTARAY® NAV ECO High Density Mapping Catheter may not be appropriate for use in patients with prosthetic valves.

The clinical significance of utilizing the CARTO® CFAE Module to help identify areas with complex fractionated atrial electrograms for catheter ablation of atrial arrhythmias, such as atrial fibrillation, has not been established by clinical investigations.

The clinical significance of utilizing the PASO® Module to help pace mapping for catheter ablation of ventricular arrhythmias has not been demonstrated by clinical investigations.

Bertaglia E, Bella PD, Tondo C, Proclemer A, Bottoni N, De Ponti R, et al. Image integration increases efficacy of paroxysmal atrial fibrillation catheter ablation: results from the CARTOMERGE® Module Italian Registry. Europace 2009;11:1004-1010.

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This site was last updated on February 1, 2021. 164930-210119