Boston Scientific Corporation has announced that it has received US Food and Drug Administration (FDA) approval of the navigation-enabled Farawave Nav ablation catheter for the treatment of paroxysmal atrial fibrillation (AF) and US FDA 510(k) clearance for its new Faraview software, which will combine to provide visualisation for cardiac ablation procedures with the company’s 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.
Today, physicians may utilise a separate mapping catheter prior to a cardiac PFA procedure to examine and analyse the heart’s electrical patterns, and plan the therapeutic applications for each patient, according to a Boston Scientific press release. 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 minimising 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 PFA 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 visualisation capabilities offered by these new technologies are designed to increase confidence in therapy delivery and simplify mapped workflows during PFA procedures.”
As the latest advancement within the Boston Scientific PFA portfolio, the Faraview software magnetically tracks the Farawave Nav ablation catheter, which allows physicians to see where pulsed fields have been applied and visualise cumulative therapy delivery to guide ablation strategy. According to the company, 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 (Mount Sinai Fuster Heart Hospital, New York, USA). “The addition of navigation and visualisation 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 USA, as stated in a press release from 18 October.
