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FARAPOINT™ Pulsed Field Ablation Catheter
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Clinical highlights
ADVANTAGE AF IDE trial: Phase II CTI cohort results
The ADVANTAGE AF US IDE trial1 studied patients with persistent atrial fibrillation (PersAF) who were treated using pulmonary vein isolation (PVI) and posterior wall ablation (PWA) with the FARAWAVE™ Pulsed Field Ablation (PFA) Catheter. The trial included adjunctive ablation of the cavotricuspid isthmus (CTI) to treat typical atrial flutter (AFL).
The trial enrolled 637 patients in two phases and allowed for a comparison of CTI ablation methods:
- Phase I (n=50): CTI ablation was performed using traditional radiofrequency ablation (RFA)
- Phase II (n=141): CTI ablation was performed using the focal FARAPOINT PFA Catheter
A prophylactic nitroglycerin (NTG) protocol was implemented to reduce the risk of coronary artery spasm during FARAPOINT CTI procedures.
96.4%
[97.5% LCL = 91.7%]
CTI effectiveness event-free rate at 12 months
0
No reports of coronary spasm (no ST segment elevation or ventricular fibrillation)
CTI Effectiveness Event-Free Rate
CTI effectiveness endpoint: The composite CTI effectiveness endpoint (acute bidirectional block and 1-year freedom from documented CTI-dependent AFL ≥ 10 sec on ECG without repeat CTI ablation) was achieved in 96.4% of the cohort.
Sub-analysis: CTI Phase I (RFA) vs CTI Phase II (PFA/FARAPOINT)2
FARAPOINT procedures were more predictable, had shorter fluoroscopy times, and significantly reduced variability in the number of CTI applications†.
| Phase I (RFA-CTI) | Phase II (PFA-CTI) FARAPOINT | |
| Patient # receiving CTI | 50 (19.2%) | 141 (55.3%) |
| CTI applications | 22.5 ± 18 | 17.5 ± 6.4 |
| Procedure time (min) | 125.3 ± 45.3 | 105.9 ± 34.9 |
| Dwell time (min) | 58.9 ± 20.2 | 59.1 ± 23.6 |
| Fluoroscopy time (min) | 24.6 ± 15.2 | 16.4 ± 12.3 |
| CTI Ablation time (min) | Not Collected | 8.4 ± 13 |
Data in table reported as Mean ± SD or n (%) as appropriate.
† Variance of number of CTI applications showed significantly lower variability with FARAPOINT-CTI vs RFA-CTI (F=8.0, p=0.001).
The focal FARAPOINT PFA Catheter provided comparable freedom from atrial flutter recurrence and safety outcomes.
Freedom from Typical AFL Recurrence
CTI Primary Safety Event Rate
Sub-analysis conclusions
- Safety rates were similar (PFA=2.1% vs RFA=2.0%; p=NS). There were no instances of clinical coronary artery spasm in those who were treated with FARAPOINT (99.0% received NTG per protocol with 54.0% receiving only 3 mg).
- The freedom from recurrence of typical AFL was similar in the two cohorts at 97.9% for FARAPOINT-CTI and 98.0% for RFA-CTI.
- Significantly lower variability with FARAPOINT PFA-CTI vs RF-CTI in number of applications and total procedure time (CTI applications F=8.0, p=0.001 and total procedure time F=1.7, p=0.02)
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How it works
The FARAPOINT PFA Catheter is designed to deliver durable focal and linear-shaped lesions with an efficient 2.5 second application time per ablation. Full integration with the FARAVIEW™ Software Module on the OPAL HDx™ Mapping System provides reliable catheter and lesion visualization required for confident PFA delivery.
CAUTION: FARAPOINT™ Pulsed Field Ablation Catheter is an Investigational Device. Limited by Federal (or US) law to investigational use only. Not available for sale.
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FARAPOINT clinical data
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Additional FARAPULSE PFA Platform resources
Find product brochures, spec sheets, clinical data compilations and more on our FARAPULSE resources page.
CAUTION: FARAPOINT™ Pulsed Field Ablation Catheter Investigational Device. Limited by Federal (or US) law to investigational use only. Not available for sale.
*Baylis Medical Company Radiofrequency Puncture Generator RFP-100A. Baylis Medical Company is a wholly owned subsidiary of Boston Scientific Corporation.
References:
1. Reddy, V., et al., "Pulsed Field Ablation of Persistent Atrial Fibrillation With Continuous ECG Monitoring Follow-Up: ADVANTAGE AF-Phase 2." Circulation 151.0 (2025).
2. Reddy, VY, et al., 2025. Focal Pulsed Field Ablation vs Standard Radiofrequency Ablation for Typical Atrial Flutter: A sub-study across Phase I and Phase II of the Pivotal ADVANTAGE AF Trial. Presented at HRS.