Medtronic Wins CE Mark for Affera Sphere-360 PFA Catheter

Reuters01-26

Medtronic Wins CE Mark for Affera Sphere-360 PFA Catheter

Medtronic plc announced that it has received CE Mark approval in Europe for the Affera™ Sphere-360™ catheter, an all-in-one mapping and single-shot pulsed field ablation (PFA) catheter for the treatment of paroxysmal atrial fibrillation. Additionally, the company has completed the first cases in the United States as part of the Horizon 360 IDE pivotal trial, which will evaluate the safety and effectiveness of the Sphere-360 catheter with the Affera mapping and ablation system.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Medtronic plc published the original content used to generate this news brief via PR Newswire (Ref. ID: CG69561) on January 23, 2026, and is solely responsible for the information contained therein.

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