FDA OKs Boston Scientific’s Navigation-Enabled Farapulse Catheter & Software

Boston Scientific has earned U.S. Food and Drug Administration (FDA) approval for its navigation-enabled Farawave NAV ablation catheter to treat paroxysmal atrial fibrillation (AFib) and 510(k) clearance for new Faraview software. These two technologies were also immediately launched in the U.S.
 
Both of these technologies allow cardiac ablation visualization with the Farapulse pulsed field ablation (PFA) system. The technologies are for exclusive use with Boston Scientific’s current cardiac mapping technology including its latest offering, the OPAL HDx mapping system.
 
The Farawave NAV ablation catheter adds magnetic navigation capabilities to enable cardiac mapping and PFA therapy delivery in one catheter. The Faraview software visually displays mapped procedures with Farapulse, offering a dynamic view of catheter placement, shape, and rotation.
 
Physicians will be able to observe where pulsed fields have been applied and visualize cumulative therapy delivery to guide ablation strategy, the company said. Automated tagging technology further helps physicians plan, execute, and confirm therapy application by displaying approximate pulsed field locations in 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.”
 
“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.”