Boston Scientific has launched its Farawave NAV ablation catheter and Faraview software after the US Food and Drug Administration (FDA) approved the two devices.
The technologies are used in conjunction with the company’s Farapulse pulsed field ablation (PFA) system to provide visualisation for cardiac ablation procedures, a treatment for atrial fibrillation (AFib). The Farapulse PFA system received FDA approval in January 2024.
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Boston Scientific noted that “these technologies are compatible exclusively with the company’s existing cardiac mapping technology including the Opal HDx Mapping System”. Additionally, the Farawave NAV ablation catheter improves on the current Farawave catheter by adding magnetic navigation capabilities, which allows physicians to see where pulsed fields have been applied and visualise cumulative therapy delivery to guide the ablation strategy.
The Farawave NAV ablation catheter also allows physicians to track the delivery of PFA through automated tagging technology by showing the approximate pulsed field locations within the heart, based on the catheter’s position.
“In clinical use, the Faraview software and the 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 Dr Vivek Reddy, director of electrophysiology, Mount Sinai Fuster Heart Hospital.
“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 AFib.”
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By GlobalDataFarapulse’s primary competitor is Medtronic’s PulseSelect, the only other FDA-approved PFA device. Despite Medtronic gaining FDA approval first, there is a stronger physician preference for Boston Scientific’s device. According to GlobalData analysis, Boston Scientific has acquired more than 74% of shares from Medtronic in the PFA space.
