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In the U.S., THERMOCOOL® Navigation Catheters are approved for drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with CARTO® Systems (excluding NAVISTAR® RMT THERMOCOOL® Catheter). Biosense Webster THERMOCOOL® Catheters are indicated for Type I Atrial Flutter in patients 18 years of age or older.
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.
THERMOCOOL® Navigation Catheters are approved for recurrent drug/device refractory sustained monomorphic ventricular tachycardia (VT) due to prior myocardial infarction (MI) in adults (excluding THERMOCOOL® SF Catheters).
The NAVISTAR® THERMOCOOL® and EZ STEER® THERMOCOOL® NAV Catheters are FDA approved for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with compatible three-dimensional electroanatomic mapping systems.
In the US, Biosense Webster THERMOCOOL® non-navigational Catheters are indicated for the treatment of Type I Atrial Flutter in patients 18 years of age or older.
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.
Always verify catheter tip location using fluoroscopy or IC signals and consult the CARTO® System User Guide regarding recommendations for fluoroscopy use.
Sporton S, Earley M, Nathan A, and Schilling R, Electroanatomic versus fluoroscopic mapping for catheter ablation procedures: A prospective randomized study. Journal of Cardiovascular Electrophysiology 2004;15,3:310-315
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.
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.
In the US, 4mm Catheters (NAVISTAR®, CELSIUS®, EZ STEER® (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.
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This site last updated on February 15, 2018.