The TactiFlex™ Duo System 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 System
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™ Quartz Equipment
Latest data just released: APHRS 2025
Flexible sedation strategies1
Acute success was evaluated under deep sedation (DS) or general anesthesia (GA) with TactiFlex Duo Ablation Catheter, SE:
No significant differences in acute safety or effectiveness across sedation groups
Skeletal muscle recruitment remained clinically acceptable1
100%
Acute success in the DS group1
99.6%
Acute success in the GA group1
Expanding beyond PVI: ablation across non-PV targets2
Initial clinical use shows TactiFlex Duo Ablation Catheter, SE in scenarios beyond PVI. In early clinical experience:
29.9%
of subjects (n = 97/324) received ablation beyond PVI2
0%
coronary spasm reported in the PVI+ group2
1%
primary safety events reported in the PVI+ group2
Clinical evidence
Before being used with patients, the TactiFlex™ Duo System, underwent extensive laboratory and pre-clinical testing. Following this, two clinical trials were initiated:
FOCALFLEX CE Mark Trial3
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 Study4
This clinical research study is intended to demonstrate safety and effectiveness of the TactiFlex™ Duo System 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 & Efficacy5
Demonstrates the safety and effectiveness of PF and RF+PF lesions delivered using the TactiFlex Duo System 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:
- Scherr, D. et al. (2025, November). General anesthesia vs. Deep sedation and Conscious Sedation in Subjects Undergoing Pulmonary Vein Isolation with a Novel Flexible-Tip Dual-Energy PF/RF Ablation Catheter [Oral Presentation]. Presented by Daniel Scherr. Asia Pacific Heart Rhythm Society (APHRS) 2025, Yokohama, Japan.
- Sanders, P. et al. (2025, November 13). Beyond Pulmonary Veins: Ablation Trends and Targets with a Novel Flexible-Tip Dual-Energy PF/RF Ablation Catheter [Oral presentation]. Presented by Prash Sanders. Asia Pacific Heart Rhythm Society (APHRS) 2025, Yokohama, Japan.
- 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 v3.0