CARDIOVASCULAR
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EXPERIENCE INNOVATIVE ABLATION TECHNOLOGY

TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ is an innovative solution for the treatment of atrial fibrillation featuring advanced handle-shaft technology and full integration with Abbott’s EnSite Precision™ cardiac mapping system.

Introducing Tacticath Catheter Sensor Enabled

INTRODUCING

Our next generation of technology — the Tacticath™ Contact Force Ablation Catheter, Sensor Enabled™ — includes a handle and shaft combination that offers maneuverability along with comfort and ease of use.1

TACTICATH™ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED™

ACCURATE

At the heart of the TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ is light interferometry technology. During bench testing, the TactiCath Contact Force Ablation Catheter, Sensor Enabled was highly accurate, with a mean accuracy of 0.3 grams.2

EFFORTLESS HANDLING*1

Feel the Difference with the Tacticath™ Contact Force Ablation Catheter, Sensor Enabled™

Ablation procedures are often long and complex. You need a catheter that gives you reliable, comfortable useablility, with the goal to lead the way in clinical outcomes. Discover a CF catheter uniquely designed for effortless handling performance.1*

  • Advanced handle-shaft combination offers maneuverability, along with comfort and ease of use1
  • Offers a variety of curve sizes to accommodate size differences in patient anatomy
INTEGRATED4,5

Discover the Synergy

No two ablation procedures are alike. Seamless integration with the Abbott EnSite Precision™ cardiac mapping system enables automated,6 flexible6*** and precise7 performance designed to improve workflow efficiency. 

 

  • Get novel insight into mapping and lesion marking through AutoMark feature advanced technology.
  • Increase procedural consistency through automated guidance of lesion marking via the AutoMark feature.4
  • Verify ablation catheter stability and AutoMark placement with the AutoTrack feature, which automatically records the precise location of the tip during radio frequency energy application.
  • Review and identify any potential gaps by viewing specific lesions from the display list.
  • Optimize your workflow with customizable CF display. 
  • Map with precision via EnSite™ AutoMap module technology — designate the system to collect mapping points only if the CF is within a specified range.4,5 
  • Uniquely integrate magnetic and impedance data. 
  • Adapt to changing needs — introduce the TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ at any point during the procedure. 4,5
REFERENCES

*Effortless handling is based on how physicians scored catheter handling characteristics during an initial market release.
**In comparison to TactiCath Quartz Contact Force Ablation Catheter.
***The open-platform feature of the EnSite Precision™ cardiac mapping system allows for use of almost any catheter, thus offering superior flexibility as compared to the CARTO‡ system by Biosense Webster‡, which limits use to Biosense Webster catheters only.
1. Abbott. Data on File. LMR Memo #90349982.
2. Abbott. Data on File. Report 90430651.
3. Abbott. Data on File. Report 90263616.
4. Abbott. Data on File. Report 90214738.
5. Abbott. Data on File. Report 90253949.
6. Ptaszek LM, Moon B, Rozen G, Mahapatra S, Mansour M. (2018). Novel automated point collection software facilitates rapid, high-density electroanatomic mapping with multiple catheter types. J Cardiovasc Electrophysiol, 29(1), 186-195. https://doi.org/10.1111/jce.13368.
7. Abbott. Data on File. Report 90237452

TACTICATH™ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED™

IRRIGATED ABLATION CATHETERS
TECHNICAL SPECIFICATIONS

Model Number

Description

Curve

French Size

Electrode Spacing (mm)

Tip Electrode (mm)

Length (cm)

A-TCSE-DD

Bi-D Irrigated Ablation Catheter

D-D

8

2-2-2

3.5

115

A-TCSE-DF

Bi-D Irrigated Ablation Catheter

D-F

8

2-2-2

3.5

115

A-TCSE-FF

Bi-D Irrigated Ablation Catheter

F-F

8

2-2-2

3.5

115

A-TCSE-FJ

Bi-D Irrigated Ablation Catheter

F-J

8

2-2-2

3.5

115

A-TCSE-JJ

Bi-D Irrigated Ablation Catheter

J-J

8

2-2-2

3.5

115

A-TCSE-D

Uni-D Irrigated Ablation Catheter

D

8

2-2-2

3.5

115

A-TCSE-F

Uni-D Irrigated Ablation Catheter

F

8

2-2-2

3.5

115

A-TCSE-J

Uni-D Irrigated Ablation Catheter

J

8

2-2-2

3.5

115

SEE FULL PRODUCT DETAILS and any references for this product.

IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION

CAUTION: This product is intended for use by or under the direction of a physician. Prior to use, reference Instructions for Use, inside the product carton (when available) or at manuals.sjm.com or eifu.abbottvascular.com for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events.

Indications: The TactiCath™ Ablation Catheter, Sensor Enabled™ is indicated for use in cardiac electrophysiological mapping and for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used in conjunction with a compatible RF generator and three-dimensional mapping system. Contraindications: Do not use for any of the following conditions: certain recent heart surgery; prosthetic valves; active systemic infection; use in coronary vasculature; myxoma or intracardiac thrombus, or an interatrial baffle or patch; retrograde trans-aortic approach in patients with aortic valve replacement.

Warnings: It is important to carefully titrate RF power; too high RF power during ablation may lead to perforation caused by steam pop. Contact force in excess of 70 g may not improve the characteristics of lesion formation and may increase the risk for perforation during manipulation of the catheter. Patients undergoing septal accessory pathway ablation are at risk for complete AV block which requires the implantation of a permanent pacemaker. Implantable pacemakers and implantable cardioverter/defibrillator may be adversely affected by RF current. Always verify the tubing and catheter have been properly cleared of air prior to inserting the catheter into the vasculature since entrapped air can cause potential injury or fatality. The temperature data transmitted by the sensor in this catheter is representative of the irrigated electrode only and does not provide tissue temperature data.

Precautions: The long-term risks of protracted fluoroscopy and creation of RF induced lesions have not been established; careful consideration must be given for the use of the device in prepubescent children. When using the catheter with conventional EP lab system or with a 3-D navigational system, careful catheter manipulation must be performed, in order to avoid cardiac damage, perforation, or tamponade. Always maintain a constant saline irrigation flow to prevent coagulation within the lumen of the catheter. Care should be taken when ablating near structures such as the sino-atrial and AV nodes.

Potential Adverse Events: Potential adverse events include, but are not limited to, cardiovascular related complications, including groin hematoma, pericardial effusion and infection. More serious complications are rare, which can include damage to the heart or blood vessels; blood clots (which may lead to stroke); tamponade; severe pulmonary vein stenosis; heart attack; esophageal fistula, or death.

Indications: The EnSite Precision™ Cardiac Mapping System is a suggested diagnostic tool in patients for whom electrophysiology studies have been indicated. The EnSite Precision™ System interfaces to either the MediGuide™ Technology System or the EnSite Precision™ Module to combine and display magnetic processed patient positioning and navigation mapping information. When used with the EnSite™ Array™ Catheter, the EnSite Precision™ Cardiac Mapping System is intended to be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone. OR, when used with an EnSite Precision™ Surface Electrode Kit, the EnSite Precision™ Cardiac Mapping System is intended to display the position of conventional electrophysiology (EP) catheters in the heart.

Warnings: Refer to the ablation catheter labeling for a listing of adverse events related to the use of this device in conjunction with radio frequency ablation, as a part of the diagnosis and treatment of cardiac arrhythmias. For patient safety, any connections that directly connect the patient to the EnSite Precision Cardiac Mapping System must be routed through the appropriate module: EnSite Precision Link, Sensor Enabled™ NavLink, EnSite Precision Field Frame, ArrayLink, CathLink, SJM ECG Cable, RecordConnect, or GenConnect. When using the EnSite Precision Module full protection against the effects of cardiac defibrillator discharge and other leakage currents is dependent upon the use of appropriate cables. Refer to the ablation catheter labeling for a listing of adverse events related to the use of this device in conjunction with radio frequency ablation, as a part of the diagnosis and treatment of cardiac arrhythmias. For patient safety, any connections that directly connect the patient to the EnSite Precision Cardiac Mapping System must be routed through the appropriate module: EnSite Precision Link, Sensor Enabled™ NavLink, EnSite Precision Field Frame, ArrayLink, CathLink, SJM ECG Cable, RecordConnect, or GenConnect. When using the EnSite Precision Module full protection against the effects of cardiac defibrillator discharge and other leakage currents is dependent upon the use of appropriate cables.

Precautions: Do not operate the EnSite Precision Field Frame within 10 meters (m) of another operating Field Frame. Do not place the EnSite Precision Field Frame cable inside the measurement volume or wrap it around the Field Frame, as it may create a magnetic interference. Do not coil the EnSite Precision Field Frame cable. The cable carries enough electric current that a magnetic field will be created when the cable is placed in a circular formation. This magnetic field may disturb the Field Frame’s magnetic field. Do not place the EnSite Precision Link, Sensor Enabled™ within 1 m of the EnSite Precision Field Frame - Do not place tool cables within 30 millimeters (mm) of the EnSite Precision Field Frame cable. If placed this close—particularly if the cables are parallel to each other—the tool cable may become subject to electromagnetic interference. Metallic equipment used in close proximity to the magnetic field during the procedure, such as a sterile drape holder, may affect Sensor Enabled (SE) points and SE field scaling accuracy. Do not use the EnSite Precision Cardiac Mapping System in the presence of other magnetic fields. Do not drop the EnSite Precision Field Frame or subject it to impact. Physical damage to the Field Frame may alter the Field Frame’s factory calibration.

Indications: When used with compatible hardware, the EnSite™ AutoMark Module is intended to automatically catalog and display various parameters associated with RF information on the 3D model in real-time.

Warnings: The AutoMark Module does not indicate lesion effectiveness. AutoMarks are placed based on user-defined parameters for catheter stability and RF metrics only. The default display for AutoMarks is 4mm gray spheres. Adjustment to display thresholds is recommended to distinguish individual AutoMarks. AutoMarks are placed based on EnGuide location. Sudden impedance changes of the body or catheter electrodes caused by the connection of other devices (e.g., stimulator, defibrillator, and other devices), poor patch adhesion or patient movement may create a location shift. Use conventional EP techniques, such as fluoroscopy or inspection of intracardiac electrogram signals, to confirm catheter location.

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