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
Safety
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
Energy type used for PVI
Ablation target
Beyond PVI ablation targets
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
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
Energy type used for PVI
Ablation target
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.
* PVI confirmation after 20-minute wait period
** After 20-minute wait period and no early reconnections
References:
- 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. - Lo, M., et al (2025, April 26). Acute Results of the FlexPulse IDE Trial [Poster presentation]. Heart Rhythm Society 2025, San Diego, CA.
- 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.
MAT-2505447 v1.0