Boston Scientific has received U.S. FDA 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.
Oct. 18, 2024 — Boston Scientific Corp. recently announced it has received U.S. Food and Drug Administration (FDA) approval for the navigation-enabled FARAWAVE NAV Ablation Catheter for the treatment of paroxysmal atrial fibrillation (AF) 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 (PFA) 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.
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."
The FARAVIEW Software magnetically tracks the FARAWAVE NAV Ablation Catheter, which allows physicians to see where pulsed fields have been applied and visualize cumulative therapy delivery to guide ablation strategy. Delivery of PFA with the FARAWAVE NAV Ablation Catheter can be tracked through automated tagging technology, which is intended to assist physicians in planning, executing and confirming application of therapy by showing the approximate pulsed field locations within the heart, based on the catheter's position.
"In clinical use, the FARAVIEW Software and FARAWAVE NAV Ablation Catheter produced detailed cardiac maps that could improve guidance, limit fluoroscopy times and assist physicians in assessing the location of energy delivered during PFA procedures," said Vivek Reddy, M.D., director of electrophysiology, Mount Sinai Fuster Heart Hospital, New York. "The addition of navigation and visualization capabilities to the FARAPULSE PFA System could aid workflow efficiency and enhance the treatment physicians can provide to patients living with AF."
Boston Scientific will immediately launch the FARAWAVE NAV Ablation Catheter and FARAVIEW Software in the U.S. For more information click here.
*Dr. Vivek Reddy is a paid consultant of Boston Scientific Corporation. He has not been compensated in connection with this press release.
May 15, 2024 
