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TactiCath

Contact Force Ablation Catheter, Sensor Enabled

TactiCath
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About TactiCath Contact Force Ablation Catheter, Sensor Enabled

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

TactiCath Contact Force Ablation Catheter, Sensor Enabled offers high accuracy1, effortless handling2,* and automated guidance.3

  • During bench testing, the TactiCath Contact Force Ablation Catheter, Sensor Enabled was highly accurate, with a mean accuracy of 0.3 grams.1
  • Advanced handle-shaft combination offers maneuverability, along with comfort and ease of use.2
  • Automated guidance of lesion marking via the AutoMark feature can increase procedural consistency.3
Product Details

TactiCath Contact Force Ablation Catheter, Sensor Enabled Product Information

Indications:

The TactiCath Contact Force 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.

TactiCath Contact Force Ablation Catheter, Sensor Enabled Clinical Evidence

Multiple clinical trials have evaluated the safety and effectiveness of the TactiCath Contact Force Ablation Catheter, Sensor Enabled. For a deep dive into the clinical data, visit the Clinical Evidence and Journal Article information.

Highlights from TactiSense IDE Study4

The TactiSense IDE study was a prospective, multi‐center, single‐arm clinical trial that demonstrated the acute safety and effectiveness of the TactiCath Contact Force Ablation Catheter, Sensor Enabled for treatment of paroxysmal atrial fibrillation (PAF).

  • 4.7% observed rate of primary safety endpoint events (one-sided 95% upper confidence limit: 8.64%)4
  • 98% of subjects who had the TactiCath Contact Force Ablation Catheter, Sensor Enabled inserted into the vasculature achieved acute procedural success. The null hypothesis was rejected and the primary effectiveness endpoint passed, since the lower bound of the one-sided 95% confidence interval was 94.95%, which was greater than the 90% performance goal.4
Primary Safety Endpoint
Primary Safety Endpoint (SAF population)Tacticath SE (N=149)Upper One-sided 95% CLPerformance Goal*P-value**
Subject experienced primary safety endpoint event (Device or procedure-related primary SAE)7 (4.7%)(8.64%)16.2%<0.0001


*One-sided upper 95% confidence limit by Clopper Pearson Method.
**One-sided p-value by using Binomial Exact Test against the performance goal of 16.2%, to be compared with one-sided significance level of 0.05.

Manuals & Resources

Manuals & Resources

Customer Service

Customer Service

*Effortless handling is based on how physicians scored catheter handling characteristics during an initial market release.

References

  1. Abbott. Data on File. Report 90430651.
  2. Abbott. Data on File. Report 90349982.
  3. Abbott. Data on File. Report 90214738.
  4. Abbott. Data on File. Report 90253949.

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Information contained herein for distribution outside the U.S. only.

CAUTION: These products are intended for use by or under the direction of a physician. Prior to use, reference the Instructions for Use, inside the product carton (when available) or online for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events.

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