*When compared with the THERMOCOOL ™ Catheter. †A constant challenge in catheter ablation is optimising electrode–tissue contact. With excellent contact, energy coupling to tissue is optimised and less energy is dissipated into the circulating blood pool. Thus, more predictable and reliable lesions can be created with excellent catheter contact to the endocardium (ESC guidelines). DELIVER UNIFORM COOLING AT ONE-HALF THE FLOW RATE.* A successful ablation requires a Smart Touch. † CATHETER STABILITY | CONTACT FORCE | FORCE VECTOR | POROUS TIP Force stability Time
Transcript
*When compared with the THERMOCOOL™ Catheter.† A constant challenge in catheter ablation is optimising electrode–tissue contact. With excellent contact, energy coupling to tissue is optimised and less energy is dissipated into the circulating blood pool. Thus, more predictable and reliable lesions can be created with excellent catheter contact to the endocardium (ESC guidelines).
DE L I V E R UNIF OR M C OOL ING AT ONE - H A L F T HE F L O W R AT E .*
A successful ablation requires a Smart Touch.†C AT HE T E R S TA BIL I T Y | C ON TA C T F OR C E | F OR C E V E C T OR | P OR OU S T IP
Force
stabilityTime
The elastomeric bridge facilitates flexibility and a smooth radius when deflected.
Greater contact force stability, greater successClinical evidence with the THERMOCOOL SMARTTOUCH™ Catheter■ In the multicentre SMART-AF clinical study,
THERMOCOOL SMARTTOUCH™ Catheter demonstrated a 74% success rate and up to an 88% success rate, depending on the stability within the contact force range1*
■ Reduce RF ablation time2
■ May improve outcomes†: Catheter–tissue contact force is critical for effective lesion creation3 §
Uniform cooling at half the flow rate‡
THERMOCOOL SMARTTOUCH™ SF Catheter■ Porous tip design enables maximum cooling
efficiency regardless of catheter orientation or power delivered
■ Reduced flow rates‡
■ Designed to achieve the level and duration of power necessary to create successful lesions
* Success defined as freedom from any symptomatic atrial arrhythmia (atrial fibrillation, atrial flutter, atrial tachycardia) 12 months postprocedure when operator remained in the preset contact force range. Further sub-analysis showed that when the contact force was within investigator-selected range ≥85% of time, success rate increased by 21% to 88% (≥85%: n=32; <85%: n=73).1
†When compared with NAVISTAR™ THERMOCOOL™ Catheter.‡When compared with the THERMOCOOL™ Catheter.§ Results based on a single-center study.
LOCATION SENSOR*Detects micro-movement of transmitter coil
TRANSMITTER COILSends location reference
PRECISION SPRING*Provides consistent movement in response to contact force
SF TIPDelivers uniform cooling with one-half of the flow rate†
Enhanced manoeuvrability and handling†‡
■ Elastomeric bridge smooths shaft radius during deflection
■ Flexibility is enhanced to facilitate access and tissue contact
■ Dual compression coils improve handling
■ Deflection is smooth and precise
■ Torque response is remarkable
Dual compression coils improve handling, deflection, and torque response.
*Cut-away view for illustration purposes only.†When compared with the THERMOCOOL™ Catheter.‡Biosense Webster, Inc., CER-0561 (data on file).
Maintain both contact force and location stability.
■ Helps to visualise and maintain catheter stability within a user-selected range
■ User-selected parameters for distance moved (measured in millimetres) over a selected time permit location stability requirement to be adjusted
Seamless integration with the CARTO™ 3 System.
■ Incorporates CARTO VISITAG™ Module technology to display key ablation parameters related to lesion formation*
■ Combines multiple parameters, including contact force, power, impedance, stability, and time at location
Observe force and catheter orientation.
■ Vector arrows show actual angle of catheter tip to tissue
■ Colour-coded catheter tip indicates progress to target force value
Get average and real-time force.
■ Accurate contact force is displayed in window and in CARTO VISITAG™ Module information grid*
■ Average force over time is presented for each ablation tag
CARTO SMARTTOUCH™ Technology adds a dimension of certainty. ■ We’ve combined our catheter technology with a graphic user interface and CARTO VISITAG™
Module to create the CARTO SMARTTOUCH™ Technology.* This allows you to select, visualise, and manage ablation parameters. Knowing this information can be helpful prospectively or retrospectively to manage your ablation strategy.
*The VISITAG™ Module provides access to data collected during the application of RF energy. The data do not indicate the effectiveness of RF energy application.
■ Provides real-time force and colour graphs based on user-defined thresholds
■ Tracks and quantifies specific parameters to determine lesion gaps and ablation progress
Knowing makes all the difference.
Indicates minimum criteria have been met
Displays increasing colour value based on time selected
Reflects maximum time RF delivery has been maintained
FORCE VECTOR DASHBOARDProvides visibility to tip angle and contact force in simple display
CARTO VISITAG™ MODULE READOUTVisualises dimensions of each RF application
CARTO SMARTTOUCH™ Technology is fully integrated with the proven CARTO™ 3 System.
FORCE VECTOR Displays force and catheter tip-to-tissue orientation
REAL-TIME GRAPHDisplays force range throughout case
■ The CARTO SMARTTOUCH™ Technology works seamlessly with your CARTO™ 3 System, displaying all parameters in real time on a single screen—providing knowledge to further support you in the quest for successful RF delivery.
THERMOCOOL™ Navigation Catheters are indicated for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with CARTO™ Systems (excluding NAVISTAR™ RMT THERMOCOOL™ Catheter).
Important information: Prior to use, refer to the instructions for use supplied with this device for indications, contraindications, side effects, warnings and precautions.
This product can only be used by healthcare professionals in US and EMEA.
This publication is not intended for distribution outside of the EMEA region
The medical device herein mentioned is a class III according to the European regulation and a regulated health product which bears the CE-Mark 0086 (BSI).
References:1. Natale A, Reddy V, Monir G, et al. Paroxysmal AF catheter ablation with a contact force sensing catheter: results of the prospective, multicenter SMART-AF Trial. J Am Coll Cardiol. 2014;64(7):647-656, and Biosense Webster, Inc., Final Clinical Report, October 2014 (data on file). 2. Martinek M, Lemes C, Sigmund E, et al. Clinical impact of an open-irrigated radiofrequency catheter with direct force measurement on atrial fibrillation ablation. Pacing Clin Electrophysiol. 2012;35(11):1312-1318. 3. Kumar S, Morton JB, Lee J, et al. Prospective characterization of catheter-tissue contact force at different anatomic sites during antral pulmonary vein isolation. Circ Arrhythm Electrophysiol. 2012;5:1124-1129.
Biosense WebsterA Division ofJohnson & Johnson Medical NV/SALeonardo Da Vincilaan 151831 Diegem, BelgiumTel: +32-2-7463-401Fax: +32-2-7463-403
■ THERMOCOOL SMARTTOUCH™Catheter demonstrated a 74% success rate and up to an 88% success rate in patients with atrial arrhythmia 12 months postprocedure1*
■ Allows active measurement of stable contact force and catheter tip direction
■ SF Tip delivers uniform cooling with half the flow rate†
■ Visually confirms delivery of user-defined dimensions of lesion creation
■ Integrates seamlessly into the CARTO™3 System
Contact your Biosense Webster, Inc. representative to find out more about CARTO SMARTTOUCH™ Technology.
Knowing makes all the difference.
* Success defined as freedom from any symptomatic atrial arrhythmia (atrial fibrillation, atrial flutter, atrial tachycardia) 12 months postprocedure when operator remained in the preset contact force range. Further sub-analysis showed that when the contact force was within investigator-selected range ≥85% of time, success rate increased by 21% to 88% (≥85%: n=32; <85%: n =73).1
