Medtronic’s Sphere-360 PFA Catheter Wins EU Nod, Has 1st IDE Cases

Medtronic announced two major milestones for its Affera Sphere-360 catheter, an all-in-one mapping and single-shot pulsed field ablation (PFA) catheter to treat paroxysmal atrial fibrillation (AFib). The Affera catheter earned CE mark clearance in Europe and the first cases in the Horizon 360 IDE pivotal trial were completed.

The Sphere-360 catheter was designed in response to physician feedback showing the need for a simple, differentiated workflow and predictable outcomes using a single catheter that accommodates anatomical variations in pulmonary veins. The catheter boasts an adjustable configuration lattice design that conforms to the shape of the veins and allows energy delivery without needing to rotate the catheter in each position.

“The Sphere-360 catheter offers an excellent balance between ease of use and consistency in outcomes. Its design conforms to the pulmonary vein in a unique way that delivers consistent, effective and durable lesions for AFib patients, without any rotation of the catheter,” said Tobias Reichlin, MD., Director of Electrophysiology at Inselspital University Hospital in Bern, Switzerland. “With the full integration into the Affera mapping system, it’s an exciting step forward for patient care in Europe.”

It delivers circumferential, consistent lesions from the entire 34 mm lattice without catheter rotation. The all-in-one catheter for navigation, mapping, and ablation needs a single transseptal puncture and no catheter exchange. Real-time local impedance information assesses catheter proximity to tissue, as well.

Results from the Sphere-360 European study at one year were presented at the Heart Rhythm Society Annual Meeting and published in the Heart Rhythm Journal in April 2025. The prospective, single-arm, multi-center trial in European centers demonstrated excellent efficacy, safety, and durability that led to CE mark.

“The achievement of CE Mark for Sphere-360, as well as the first cases in the U.S. IDE trial, mark two major achievements in our effort to deliver new and better treatments to AFib patients,” said Rebecca Seidel, president of Medtronic’s Cardiac Ablation Solutions business. “We’re committed to leading in PFA and bringing meaningful innovation at a regular cadence.”