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TactiFlexTM Duo Ablation Catheter, Sensor EnabledTM

TactiFelx Duo Ablation Catheter

The TactiFlex™ Duo Ablation Catheter, Sensor Enabled™ is investigational and not approved for sale in any geography. The Current™ PFA Generator has received CE Mark; it is not available in all geographies.

 

TactiFlex™ Duo Ablation Catheter, Sensor Enabled™

The PFA components of the system consist of the following:

  • TactiFlex™ Duo Ablation Catheter, Sensor Enabled™: A novel dual energy, flexible-tip focal ablation catheter that can transmit either RF energy or PFA therapy. It is designed for therapy delivery, pacing, and collection of electrical and anatomical data when used with the EnSite™ X EP System.
  • Current ™ PFA Generator: The streamlined user interface includes energy source selection and PFA waveform selection. Abbott’s Current PFA Generator is designed for intuitive use and can also be used with the Volt™ PFA Catheter, Sensor Enabled™.

The RFA components of the system consist of the following:

  • Ampere™ RF Generator
  • CoolPoint™ Pump
  • TactiSys™ contact force unit

Clinical evidence

Before being used with patients, the TactiFlex™ Duo Ablation Catheter, Sensor Enabled™ underwent extensive laboratory and pre-clinical testing. Following this, two clinical trials were initiated:

FOCALFLEX CE Mark Trial1

Effectiveness

99.6% acute effectiveness
94.2% first pass isolation
99.3%acute effectiveness
89.6% first pass isolation

Safety

TactiFlex FOCALFLEX safety chart

Procedural information

Total PV ablation time:
Median (Q1,Q3): 43.0 (36.0, 55.0) min

 

Total PFA applications for PVI:
93.5 ± 32.9 PFA applications/patient

Sedation method

TactiFlex FOCALFLEX sedation method

Energy type used for PVI

TactiFlex FOCALFLEX energy type used for PVI

Ablation target

TactiFlex FOCALFLEX ablation target

Beyond PVI ablation targets

TactiFlex FOCALFLEX beyond PVI ablation targets

Demographics

TactiFlex FOCALFLEX demographics

FlexPulse IDE Study2

This clinical research study is intended to demonstrate safety and effectiveness of the TactiFlex Duo Ablation Catheter, SE and Current PFA Generator for the treatment of symptomatic, recurrent, drug refractory paroxysmal atrial fibrillation.

View FlexPulse IDE Study Design

Demographics

TactiFlex FLEXPULSE demographics

Effectiveness

100%

Acute effectiveness
(n=166/166)

Procedural Information

Total PV ablation time:
Median (Q1,Q3): 45.5 (35.0, 60.0) min

 

Total PFA applications for PVI:
101.9 ± 26.0 PFA applications/patient

Sedation method

TactiFlex FLEXPULSE ssedation method

Energy type used for PVI

TactiFlex FLEXPULSE energy type used for PVI

Ablation target

Ablation target

Beyond PVI ablation targets

TactiFlex FLEXPULSE beyond PVI ablation targets

Pre-clinical data

2025 HRS Abstract: Chronic Canine Safety & Efficacy3

Demonstrates the safety and effectiveness of PF and RF+PF lesions delivered using the TactiFlex Duo catheter in creation of focal, linear, and circumferential atrail lesion sets using two distinct PFA waveforms.

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* PVI confirmation after 20-minute wait period
** After 20-minute wait period and no early reconnections

References:

  1. Silberbauer, J., et al (2025, April 25). Initial Clinical Experience with the TactiFlex DUO System: Safety and Acute Results of the FOCALFLEX Study
    [Oral presentation]. Presented by Daniel Scherr. Heart Rhythm Society 2025, San Diego, CA.
  2. Lo, M., et al (2025, April 26). Acute Results of the FlexPulse IDE Trial [Poster presentation]. Heart Rhythm Society 2025, San Diego, CA.
  3. Koruth, J. et al. Acute and chronic pulmonary vein isolation durability and safety assessments of a focal dual-energy, flexible 4mm contact-sensing tip [Poster presentation]. Heart Rhythm Society 2025, San Diego, CA.

Rx Only. Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events, and directions for use.

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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.

Illustrations are artist's representations only and should not be considered as engineering drawings or photographs.

Unless otherwise specified, all product 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. ™ Indicates a trademark of the Abbott group of companies. ‡ Indicates a third party trademark, which is property of its respective owner.

© 2025 Abbott. All Rights Reserved.

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