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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

  • Tacticath Contact Force Ablation Catheter, Sensor Enabled Product Information

    Product Details

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% CL Performance 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.

Reimbursement & Coding Highlights

Our reimbursement resource documents provide information about coverage, coding and payment, denied claims and supporting documentation for the TactiCath Contact Force Ablation Catheter, Sensor Enabled.

Common CPT Code Modifiers

This document provides a printable form for easy CPT coding reference.

Catheter Ablation and Related Procedures: Frequently Used CPT‡ Codes – Hospital Outpatient and Physician Services

This document provides a printable form for easy Current Procedural Terminology (CPT) coding reference.

Abbott Therapy Coding Guide: 2020 HCPCS Device Category C-Codes

This document provides a current list of reimbursement Healthcare Procedural Coding System (HCPCS) Device Category C-codes.



For the full resource list, visit Reimbursement & Coding for the TactiCath Ablation Catheter, Sensor Enabled.

*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.
Indications, Safety & Warnings

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© 2019 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.

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