30
CARDIOVASCULAR
hamburger

Ablation Technology

Ablation procedures are often long and complex. You need a catheter that offers reliability and comfortable usability, and helps you achieve successful clinical outcomes. We offer innovations in ablation technologies that support your needs and are tailored for differences in your patients’ anatomies and conditions.

FlexAbility Ablation Catheter, Sensor Enabled

Designed to enhance procedural versatility and precision when integrated with Abbott mapping and navigation systems, the FlexAbility ablation catheter, Sensor Enabled™, was created to facilitate detailed, accurate model creation1 and effective lesion creation.2

FlexAbility Irrigated Ablation Catheter

With its unique flexible tip and advanced shaft and handle combination, the FlexAbility™ irrigated ablation catheter is the Abbott response to the industry need for a predictable, durable cardiac ablation catheter with a strong safety and efficacy profile.3-6

TactiCath Contact Force Ablation Catheter, Sensor Enabled

TactiCath™ contact force ablation catheter, Sensor Enabled™ features advanced handle-shaft technology for maneuverability, comfort and ease of use,7 and offers full integration with Abbott’s EnSite Precision™ cardiac mapping system.

  • Manuals & Technical Resources
  • Cardiovascular Products
  • Customer Service

References

  1. Abbott. Data on file. Report 90213470.
  2. Abbott. Data on file. Report 90122753. Based on Therapy™ Cool Flex™ ablation catheter tip.
  3. Abbott. Data on file. Report 90058001.
  4. Abbott. Data on file. Report 90122753, based on Therapy™ Cool Flex™ ablation catheter tip.
  5. Peichl,P., & Kautzner, J. (2013). Advances in irrigated tip catheter technology for treatment of cardiac arrhythmias. Recent Patents on Cardiovascular Drug Discovery, 8(1), 10-16.
  6. Winterfield, J. R., Jensen, J., Gilbert, T., Marchlinski, F., Natale, A., Packer, D., . . . Wilber, D. J. (2016). Lesion size and safety comparison between the Novel flex tip on the FlexAbility ablation catheter and the solid tips on the ThermoCool and ThermoCool SF ablation catheters. Journal of Cardiovascular Electrophysiology, 27(1),102-109.
  7. Abbott. Data on File. LMR Memo 90349982.

Indications, Safety & Warnings

FlexAbility Ablation Catheter, Sensor Enabled

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 eifu.abbottvascular.com or at manuals.sjm.com for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events.

Indications:  The FlexAbility™ Ablation Catheter, Sensor Enabled™ is intended for use with the compatible irrigation pump and a compatible RF cardiac ablation generator. The catheter is intended for creating endocardial lesions during cardiac ablation procedures (mapping, stimulation, and ablation) for the treatment of typical atrial flutter.

Contraindications: In patients with active systemic infection. In patients with intracardiac mural thrombus or those who have had a ventriculotomy or atriotomy within the preceding four weeks.

Warnings:  Catheter ablation procedures present the potential for significant x-ray exposure. The long-term risk of protracted fluoroscopy has not been established. Careful consideration must be given for the use of the device in prepubescent children and pregnant women. The long terms risks of RF ablation lesions have not been established. The temperature data transmitted by the sensor in this catheter is representative of the irrigated electrode only and does not provide tissue temperature data. 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.

Precautions:  If the irrigation pump alarm sounds, terminate RF delivery. If impedance rises suddenly that does not exceed the preset limit, power delivery should be manually discontinued. Always maintain constant irrigation to prevent coagulation within and around electrodes. Irrigated ablation systems have been shown to create larger lesions than standard radiofrequency ablation catheters. Care should be taken when ablation near electrically vulnerable, thin-walled or other arterial structures. If irrigation is interrupted, immediately inspect and reflush the catheter outside of the patient. Reestablish irrigation flow prior to placing catheter in the body. Do not attempt ablation without using an irrigation pump.

Potential adverse events:  Potential adverse events include, but are not limited to, cardiovascular and anesthesia-related complications, including inadvertent AV block. Please refer to the Instructions for Use of a complete list.

FlexAbility Ablation Catheter

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 eifu.abbottvascular.com or at manuals.sjm.com for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events.

Indications: The FlexAbility™ Ablation Catheter is intended for use with the compatible irrigation pump and a compatible RF cardiac ablation generator. The catheter is intended for creating endocardial lesions during cardiac ablation procedures (mapping, stimulation, and ablation) for the treatment of typical atrial flutter.

Contraindications:  In patients with active systemic infection. In patients with intracardiac mural thrombus or those who have had a ventriculotomy or atriotomy within the preceding four weeks.

Warnings: Catheter ablation procedures present the potential for significant x-ray exposure. The long-term risk of protracted fluoroscopy has not been established. Careful consideration must be given for the use of the device in prepubescent children and pregnant women. The long terms risks of RF ablation lesions have not been established. The temperature data transmitted by the sensor in this catheter is representative of the irrigated electrode only and does not provide tissue temperature data. 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.

Precautions: If the irrigation pump alarm sounds, terminate RF delivery. If impedance rises suddenly that does not exceed the preset limit, power delivery should be manually discontinued. Always maintain constant irrigation to prevent coagulation within and around electrodes. Irrigated ablation systems have been shown to create larger lesions than standard radiofrequency ablation catheters. Care should be taken when ablation near electrically vulnerable, thin-walled or other arterial structures. If irrigation is interrupted, immediately inspect and reflush the catheter outside of the patient. Reestablish irrigation flow prior to placing catheter in the body. Do not attempt ablation without using an irrigation pump.

Potential adverse events:  Potential adverse events include, but are not limited to, cardiovascular and anesthesia-related complications, including inadvertent AV block. Please refer to the Instructions for Use of a complete list.

Tacticath SE

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.

MAT-2008460 v1.0

DO YOU WISH TO CONTINUE AND EXIT CARDIOVASCULAR.ABBOTT?

CONTENTS OF THE SITE ARE NOT UNDER THE CONTROL OF ABBOTT.

True
accessibility
© 2016 Abbott. All Rights Reserved. Please read the Legal Notice for further details.

Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company.

accessibility

DO YOU WISH TO CONTINUE AND EXIT CARDIOVASCULAR.ABBOTT?

CONTENTS OF THE SITE ARE NOT UNDER THE CONTROL OF ABBOTT.