The two technologies comprise part of the company’s Farapulse pulsed field ablation (PFA) system. Boston Scientific initially won FDA approval for Farapulse in January. In doing so, it became second company to earn an FDA nod for PFA that treats AFib. Medtronic picked up the first approval for PFA to treat paroxysmal and persistent AFib in December.
Farawave Nav and Faraview combine to provide visualization for cardiac ablation procedures to treat AFib. They’re compatible exclusively with Boston Scientific’s existing cardiac mapping technology and its latest offering, the Opal HDx mapping system.
More about the newly approved Boston Scientific PFA tech
According to a news release, physicians may utilize a separate mapping catheter prior to a cardiac PFA procedure. This allows them to examine and analyze the heart’s electrical patterns and plan the therapeutic applications for each patient. Farawave Nav builds upon the current Farwave catheter by adding magnetic navigation capabilities. This enables cardiac mapping and PFA delivery within a single integrated catheter and minimizes the need for additional device exchanges.
Faraview software depicts mapped procedures with Farapulse, providing a dynamic view of catheter placement, shape and rotation. It magnetically tracks the catheter to give physicians a view of where pulsed fields have been applied. They can visualize cumulative therapy delivery to guide ablation strategy.
Boston Scientific plans to immediately launch the catheter and software in the U.S.
“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.”
