Boston Scientific has received the US Food and Drug Administration (FDA) approval for Farawave Nav, a navigation-enabled ablation catheter for paroxysmal atrial fibrillation (AF).
The US-based biomedical engineering company also received FDA 510(k) approval for the Faraview software module.
The Farawave Nav Catheter and Faraview software jointly provide visualisation for cardiac ablation procedures with the Farapulse Pulsed Field Ablation (PFA) System.
The technologies are compatible with Boston Scientific’s existing cardiac mapping technology and its latest offering, the OPAL HDx Mapping System.
Boston Scientific is planning to commercialise the Farawave Nav Ablation Catheter and Faraview Software immediately in the US.
Boston Scientific electrophysiology president Nick Spadea-Anello said: “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.
“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.”
According to the company, physicians currently use a separate mapping catheter to examine the heart’s electrical patterns before the cardiac PFA procedure.
Boston Scientific said that its Farawave NAV Ablation Catheter builds upon its Farawave catheter, with additional magnetic navigation capabilities.
It enables the cardiac mapping and PFA therapy delivery within a single integrated catheter while minimising the need for additional device exchanges.
The Faraview software represents the latest addition to Boston Scientific’s PFA portfolio.
The software can track PFA delivery with the Farawave Nav catheter through its automated tagging technology, helping physicians plan, execute, and confirm therapy applications.
Faraview Software offers a dynamic view of catheter placement, shape, and rotation, allowing physicians to visually depict mapped procedures with the Farapulse PFA System.
Mount Sinai Fuster Heart Hospital electrophysiology director Vivek Reddy said: “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.
“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.”
