Medtronic Secures CE Mark for Sphere-360 PFA Catheter

Medtronic announced that its Affera Sphere-360 pulsed field ablation (PFA) catheter received a CE mark for treating paroxysmal atrial fibrillation. Unlike Boston Scientific’s Farawave catheter, Sphere-360 is a single-shot device that ablates target tissue without requiring rotation, aiming to simplify procedures and improve consistency.

The company reported a more than 300% increase in PFA sales in Q2 and has begun a pivotal U.S. clinical trial, with primary completion expected in November 2027. Sphere-360 builds on Medtronic’s existing PFA portfolio, which includes the Sphere-9 and PulseSelect catheters, combining rapid pulmonary vein isolation with durable outcomes.

Physicians praise Sphere-360 for its conforming design and short procedure times; one-year data show a pulmonary vein isolation time of 11.5 minutes. Medtronic also emphasized that the device is engineered for a lower cost base than Sphere-9, supporting higher profit margins while directly competing with existing single-shot PFA technologies.

26-01-2026