New FARAWAVETM NAV Ablation Catheter and FARAVIEWTM Software combine with OPAL HDxTM Mapping System to provide visualization during pulsed field ablation MARLBOROUGH, Mass. , Oct. 18, 2024 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX ) today announced it has received U.
S. Food and Drug Administration (FDA) approval for the navigation-enabled FARAWAVETM NAV Ablation Catheter for the treatment of paroxysmal atrial fibrillation (AF) and FDA 510(k) clearance for the new FARAVIEWTM Software, which will combine to provide visualization for cardiac ablation procedures with the FARAPULSETM Pulsed Field Ablation (PFA) System. These technologies are compatible exclusively with Boston Scientific's existing cardiac mapping technology and the company's latest offering, the OPAL HDxTM 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 Abla.