Boston Scientific launches next-gen cardiac mapping for FARAPULSE

Boston Scientific (BSX) Corporation announced it has received U.S. Food and Drug Administration approval for the navigation-enabled FARAWAVE NAV Ablation Catheter for the treatment of paroxysmal atrial fibrillation and FDA 510(k) clearance for the new FARAVIEW Software, which will combine to provide visualization for cardiac ablation procedures with the FARAPULSE Pulsed Field Ablation System. These technologies are compatible exclusively with Boston Scientific’s existing cardiac mapping technology and the company’s latest offering, the OPAL HDx Mapping System. Today, physicians may utilize a separate mapping catheter prior to a cardiac PFA procedure to examine and analyze the heart’s electrical patterns and plan the therapeutic applications for each patient. The FARAWAVE NAV Ablation Catheter builds upon the current FARAWAVE catheter by adding magnetic navigation capabilities, enabling cardiac mapping and PFA therapy delivery within a single integrated catheter, while minimizing the need for additional device exchanges. Mapped procedures with the FARAPULSE PFA System are visually depicted for physicians via the FARAVIEW Software, which offers a dynamic view of catheter placement, shape and rotation. “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.”