Boston Scientific Unveils Cardiac Mapping for Farapulse PFA System

Boston Scientific Corporation, a leading global medical technology company, stated it got approval from the US FDA for the Farawave NAV Ablation Catheter and FDA 510(k) clearance for the Faraview Software, both used in treating paroxysmal atrial fibrillation (AF) along with the Farapulse Pulsed Field Ablation (PFA) System for cardiac ablation procedures. These technologies only work with Boston Scientific's current cardiac mapping technology and their newest product, the OPAL HDx Mapping System.

Currently, doctors can use a distinct mapping catheter before a cardiac PFA operation to study the heart's electrical patterns and strategize the therapeutic treatments for each individual. The Farawave NAV Ablation Catheter improves upon the existing Farawave catheter with magnetic navigation features, allowing for cardiac mapping and PFA therapy in one catheter, reducing the need for extra device changes. Physicians are provided with visual representations of mapped procedures using the Faraview Software with the Farapulse PFA System, showing catheter placement, shape, and rotation dynamically.

"The addition of the Farawave NAV Ablation Catheter and Faraview Software to our portfolio provides a next-level pulsed field ablation mapping experience with cost-effective tools developed specifically and uniquely for the Farapulse PFA System," said Nick Spadea-Anello, president, Electrophysiology, Boston Scientific. "Built on this safe and clinically-proven platform – which has been used to treat more than 125,000 patients globally – the visualization capabilities offered by these new technologies are designed to increase confidence in therapy delivery and simplify mapped workflows during PFA procedures."