Boston Scientific's Farapulse System Gains FDA Nod for Enhanced Cardiac Mapping

Key Insights

• Boston Scientific received FDA approval for the Farawave Nav Ablation Catheter, enhancing cardiac mapping and pulsed field ablation (PFA) for paroxysmal atrial fibrillation (AF).
• The new Faraview software gained FDA 510(k) clearance, offering visualization for cardiac ablation procedures using the Farapulse PFA system.
• The integrated system provides physicians with a dynamic view of catheter placement and pulsed field application, potentially improving workflow and treatment efficacy.

Boston Scientific Corporation has announced FDA approval for its Farawave Nav Ablation Catheter and 510(k) clearance for the Faraview Software, marking a significant advancement in the treatment of paroxysmal atrial fibrillation (AF). The new tools enhance the Farapulse Pulsed Field Ablation (PFA) System by integrating cardiac mapping and visualization capabilities, potentially improving the precision and efficiency of ablation procedures.

The Farawave Nav Ablation Catheter builds on the existing Farawave catheter by incorporating magnetic navigation. This allows for cardiac mapping and PFA therapy delivery through a single catheter, reducing the need for device exchanges. The Faraview Software provides physicians with a dynamic visualization of catheter placement, shape, and rotation during procedures using the Farapulse PFA System.

Enhanced Visualization and Precision

The Faraview Software magnetically tracks the Farawave Nav Ablation Catheter, enabling physicians to visualize where pulsed fields have been applied and to monitor cumulative therapy delivery. Automated tagging technology assists in planning, executing, and confirming therapy application by displaying the approximate pulsed field locations within the heart based on the catheter's position.

According to Dr. Vivek Reddy, director of electrophysiology at Mount Sinai Fuster Heart Hospital, "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."

Clinical Implications and Availability

The integration of navigation and visualization capabilities into the Farapulse PFA System is expected to improve workflow efficiency and enhance treatment outcomes for patients with AF. Boston Scientific has announced the immediate launch of the Farawave Nav Ablation Catheter and Faraview Software in the U.S.

Nick Spadea-Anello, president of Electrophysiology at Boston Scientific, stated, "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," noting that the platform has already been used to treat over 125,000 patients globally.