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.