Boston Scientific has gained a duo of CE markings in the European Union (EU) for its navigation enabled Farawave NAV Ablation Catheter for paroxysmal atrial fibrillation (AF) treatment and its new Faraview software.
The technologies will expand the mapping options for cardiac ablation procedures conducted using Boston Farapulse Pulsed Field Ablation (PFA) System, which gained a CE mark in Europe in 2021 and marketing approval from the US Food and Drug Administration (FDA) in January 2024.
Farapulse PFA is a nonthermal treatment which selectively applies electric fields for ablating heart tissue in patients with AF, an irregular heartbeat disorder that can lead to blood clots in the heart and increase the risk of developing other heart problems.
The system is part of the cardiac rhythm management (CRM) space, which encompasses a broader group of devices used to restore the natural synchronised pumping rhythm of the heart.
Boston Scientific said the Farawave NAV Ablation Catheter iterates on the current Farawave catheter by adding magnetic navigation, meaning cardiac mapping and PFA therapy can be performed with a single catheter, reducing the need for device changes.
The Faraview software visualises mapped procedures conducted with Farapulse, providing doctors with a view of catheter placement, shape, and rotation.
Caroline Bravo, vice president of rhythm management for Boston Scientific, EMEA region, said: “Integrated mapping technology with a single catheter solution will set a new standard for clinical innovation and therapy delivery.
“The Farawave NAV Ablation Catheter and Faraview software are designed specifically for the Farapulse PFA system, and have the potential to increase workflow options, maintain efficiency and enhance the treatment physicians can provide to patients living with AF.”
Boston Scientific’s recent financial report revealed that its electrophysiology sales grew 172% in Q4 2024, driven by an uptake of Farapulse.
According to GlobalData analysis, since the FDA approval of Medtronic’s PulseSelect PFA system in December 2021 and Boston Scientific’s Farapulse in January 2024, the PFA market has grown to over $500m.
