Description

The FARAVIEW Software Module, seamlessly integrated with the OPAL HDx™ Mapping System, is an advanced cardiac mapping solution that dynamically visualizes the size, shape, and rotation of the FARAWAVE™ NAV Pulsed Field Ablation (PFA) Catheter.

The FARAVIEW Software Module offers a visionary approach to PFA, providing a single-catheter solution for mapping and ablating via the magnetically-tracked FARAWAVE™ NAV Pulsed Field Ablation (PFA) Catheter. This industry-leading integrated solution delivers dynamic visualization that allows operators to plan, execute, and confirm workflows, further supporting seamlessly efficient procedures on the OPAL HDx™ Mapping System.

NAVIGATE-PF trial
The NAVIGATE-PF clinical trial was a multi-center, first-in-human feasibility study that assessed the acute and chronic accuracy of FIELDTAG™ Technology on the FARAVIEW™ Software Module in visualizing pulsed field energy delivery by the FARAWAVE™ NAV Pulsed Field Ablation (PFA) Catheter. The study included two phases:

Phase I (acute assessment):
Phase 1 included 30 patients that underwent PV isolation, with 30% also receiving posterior wall ablation.
PFA markers were placed during PFA application and high-quality, post-ablation HD maps with INTELLAMAP ORION™ Mapping Catheter were completed in 15 pts. PFA markers were overlaid on the HD map and contours were drawn at the outer border of the low voltage areas (defined as ≤0.5mV) where at least 2 overlapping PFA markers were dropped.

Phase II (chronic assessment):
Included 20 patients at 1 center to evaluate chronic lesion durability and alignment between acute PFA tag locations and chronic low voltage borders.

FARAVIEW Software Module technical specifications
The FARAVIEW Software Module is available only on the OPAL HDx Mapping System and fully integrates with the FARAPULSE PFA System using the FARAWAVE™ NAV PFA Catheter. See OPAL HDx technical specifications for more information.