The Farapulse pulsed-field ablation system’s Farawave catheter (pictured) uses an energy field generated by the Farastar to treat atrial fibrillation. [Image courtesy of Boston Scientific]
“Demand for the platform far exceeds our ability to supply thus far,” Boston Scientific Chair and CEO Mike Mahoney said on yesterday’s earnings call.
He soon after shared that the device developer “just recently received GMED approval for a manufacturing approval to actually manufacture this in Minnesota.”
Paris-based GMED is a notified body designated by France for conformity assessment under the EU Medical Devices Regulation (MDR).
Farapulse Inc. secured CE mark approval for the system before being acquired by Boston Scientific in 2021. The system is not yet approved by the FDA for use in the U.S.
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“We expect a significant increase in availability of new accounts in the fourth quarter of 2023 and that continuing on in 2024 well in advance of the launch in the U.S.,” Mahoney said.
A spokesperson for Marlborough, Massachusetts-based Boston Scientific confirmed the approval, saying it applies to the Farapulse PFA System’s Farastar pulsed field ablation generator. The Farapulse PFA system also includes the Farawave catheter and Faradrive steerable sheath. All work together to deliver electric field ablation inside the heart to treat atrial fibrillation.
Related: What is pulsed-field ablation? Here’s what you need to know
Mahoney didn’t mention where in Minnesota the device developer would manufacture the additional generators, and the spokesperson had few details to share.
“This will be the second location within our network where these generators are manufactured,” spokesperson Sabrina Rubin Erdely said in an email.
The FDA’s database of registered manufacturing plants includes only one already making Farastar pulse generators: Cintron Medical Corp. in Westminster, Colorado.
It’s not clear whether Boston Scientific will make the generators at the second site or if a contract manufacturer will handle them.
The FDA’s manufacturing site database also includes a single location for Farapulse Inc. The Menlo Park, California, site is listed for export-only manufacturing of percutaneous cardiac ablation catheters for treatment of atrial fibrillation.
Boston Scientific’s latest annual report lists Minnesota manufacturing operations in Arden Hills and Maple Grove.
Boston Scientific intends to expand elsewhere in Maple Grove with a new divisional headquarters campus, including space for its interventional cardiology, peripheral interventions, urology and Watchman divisions. Plans for that project include offices, labs and training space, as well as room for future expansion. Construction on that project could start as soon as this fall.
Related: 5 keys to Mike Mahoney and Boston Scientific’s success
