SVP and President of Electrophysiology, Nick Spadea-Anello, posted on LinkedIn yesterday evening to congratulate the company for receiving FDA approval for Farapoint. He noted that the approval “closely follows” CE mark for the device, which Boston Scientific picked up last month.
Spadea-Anello said approval “adds another PFA tool to the Farapulse PFA platform.” He said it gives electrophysiologists a nav-enabled PFA solution that creates both focal and linear-shaped lesions with the same catheter.
The FDA nod enables the company to bring the newest PFA catheter in its electrophysiology portfolio to the U.S. market. Farapoint received approval as an adjunctive catheter for ablating the cavotricuspid isthmus (CTI) area of the heart when the Farawave PFA catheter is used in the treatment of drug-refractory, symptomatic persistent AFib.
Learn more about Boston Scientific’s PFA technology in the MassDevice Cardio Device Companies Special Report.
Farapoint and Farawave are components of the Farapulse PFA system originally developed to treat AFib. Farapulse received a much-anticipated FDA approval in 2024. It has Boston Scientific pushing to become the top player in the electrophysiology space. Spadea-Anello said the combination of Farapoint and Faraview on the Opal HDx mapping system provides enhanced visualization of the catheter and lesion formation. This supports confident and controlled PFA delivery.
Boston Scientific has future launches planned, including the Farapoint and Faraflex features of the Farapulse system. Farapoint is expected to launch by the end of this year, with the first rollout set for the EMEA region. Faraflex, a mapping and PFA catheter, remains in the pipeline as well, with ongoing clincial trials.
“Thank you to our amazing global team at Boston Scientific and to the many physicians who have helped guide and shape this technology,” Spadea-Anello said. “This milestone is the result of years of collaboration and tireless dedication to advance AF treatment for our customers and their patients.”
