Cardiac catheter FARAPOINT™

steerable8 FR

Overview
The FARAPOINT™ Pulsed Field Ablation (PFA) Catheter provides focal precision within the FARAPULSE™ PFA Platform, enabling electrophysiologists to perform both point‑by‑point focal lesions and linear lesion sets using a single nav‑enabled catheter. It is engineered for workflow versatility and consistent lesion depth across applications.

Key features

• Creates focal and linear‑shaped lesions via point‑by‑point workflows
• 2.5 second application time per ablation
• Nav‑enabled (magnetic navigation) for full visualization of catheter position
• FIELDTAG™ Technology to support controlled PFA delivery
• Fully integrated with FARAVIEW™ Software Module and OPAL HDx™ Mapping System
• Preclinical lesion depths up to 8.0 mm at 2.0 kV (lesion depth varies with number of applications: 2 apps ≈ 4–5 mm; 4 apps ≈ 6–8 mm)

How it works
The catheter delivers bipolar, biphasic pulsed field energy through a focal electrode configuration to ablate cardiac tissue with rapid, predictable applications and magnetic navigation support.

Clinical highlights

• Evaluated in the ADVANTAGE AF IDE trial (Phase II and subanalyses)
• Applied in pulmonary vein isolation (PVI) and posterior wall ablation (PWA) workflows; trial included adjunctive cavotricuspid isthmus (CTI) ablation
• CTI effectiveness event‑free rate at 12 months reported as 96.4% (97.5% LCL = 91.7%)
• No clinical coronary artery spasm reported in the FARAPOINT CTI subcohort
• Compared with RFA CTI (Phase I vs Phase II subanalysis): FARAPOINT procedures showed shorter fluoroscopy times, more predictable performance, and significantly lower variability in number of CTI applications

CTI Phase I (RFA) vs Phase II (PFA/FARAPOINT) — selected comparison (table)
Header: | 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

Real‑world / practical notes
The catheter is designed to address anatomic challenges such as ridges, pouches and tissue substrate variation, enabling consistent lesion depth across focal and linear applications.

Required / compatible products

• FARASTAR™ Pulsed Field Ablation Generator (platform generator)
• FARADRIVE™ Steerable Sheath (steerable 8.5F sheath compatibility)
• VersaCross™ Steerable Access Solution / VersaCross Connect™ Access Solution for FARADRIVE™
• OPAL HDx™ Mapping System and FARAVIEW™ Software Module (integration for mapping and visualization)

Ordering information (selected)

• FARAPOINT PFA Catheter (D‑F Curve) — Reference: M004PF81M110
• FARAPOINT PFA Catheter (F‑F Curve) — Reference: M004PF81M310

Accessories (selected)

• PFA Gen 2 Connection Cable for FARAPOINT — Reference: M004PF41M444

Technical specifications

• Catheter type: Focal
• Energy modality: Bipolar, biphasic PFA
• Tip diameter: 2.5 mm
• Shaft diameter: 8F
• Usable length: 115 cm
• Number of electrodes: 4
• Electrode spacing: 1.5 mm – 6.0 mm – 1.5 mm
• Electrode sizing: 2.0 mm – 1.5 mm – 1.5 mm – 2.0 mm
• Sheath compatibility: Any 8.5F sheath
• Boston Scientific compatible: FARADRIVE™ Steerable Sheath (M004PF21M402); VERSACROSS™ Steerable 8.5F
• VersaCross integration: VersaCross Connect™ Access Solution for FARADRIVE™; VersaCross™ Steerable Access Solution