Medtronic plc has announced that its Affera Sphere-360 catheter, designed for the treatment of paroxysmal atrial fibrillation (AFib), has received CE Mark approval in Europe and completed first cases in the Horizon 360 IDE pivotal trial in the United States.
The Sphere-360 catheter is a single-shot pulsed field ablation (PFA) device that integrates mapping and ablation capabilities. It features an adjustable lattice design intended to conform to different pulmonary vein anatomies and deliver energy without requiring rotation at each position. The device is fully compatible with the Affera mapping and ablation system.
Physicians in several regions have already adopted the Affera mapping and ablation system along with the Sphere-9 catheter, citing safety and durability. Tobias Reichlin, M.D., Director of Electrophysiology at Inselspital University Hospital in Bern, Switzerland, said: “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. With the full integration into the Affera mapping system, it’s an exciting step forward for patient care in Europe.”
The Sphere-360 catheter provides circumferential lesion delivery from its 34 mm lattice without rotation, adapts to patient anatomy, enables navigation, mapping, and ablation through a single transseptal puncture with no need for catheter exchange, offers real-time local impedance data for tissue proximity assessment, and uses an over-the-wire design for stability. It is also compatible with FlexCath Contour 10 French deflectable sheath.
Vivek Reddy, M.D., Director of Cardiac Arrhythmia Services at Mount Sinai Health System in New York City stated: “Advances in electrophysiology over the past several years are having a significant impact on care for arrhythmia patients, and Affera has been a key part of that impact. Now with Sphere-360, we have a new and differentiated single-shot PFA catheter with the potential to deliver the next phase of innovation. It’s an exciting time for physicians and patients and we’re not slowing down.”
Results from a European study on Sphere-360 were presented at a major cardiology meeting and published in April 2025. The study was prospective, single-arm, multi-center across European sites and showed positive efficacy, safety, and durability results leading to CE Mark approval.
Rebecca Seidel, president of Medtronic’s Cardiac Ablation Solutions business unit said: “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. We’re committed to leading in PFA and bringing meaningful innovation at a regular cadence.”
The Horizon 360 IDE study is being conducted at centers across the United States to evaluate safety and effectiveness of this technology for treating paroxysmal AFib.
Medtronic was previously first to offer two PFA systems globally: PulseSelect Pulsed Field Ablation System—available now in more than 35 countries—and Sphere-9 all-in-one dual energy mapping/ablation catheter used for persistent AFib or CTI-dependent atrial flutter. The Affera system with Sphere-9 is approved across multiple regions including Europe, Australia/New Zealand, Japan, as well as having received FDA approval.
Atrial fibrillation affects more than 60 million people worldwide; it often progresses from intermittent episodes (paroxysmal) to persistent forms associated with increased risks such as heart failure or stroke.
Medtronic plc is headquartered in Galway, Ireland. The company employs over 95,000 people globally across more than 150 countries. Medtronic develops technologies addressing about 70 health conditions including cardiac devices and surgical tools; further information can be found at www.Medtronic.com.
“Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.”
Dr. Reddy is a paid consultant for Medtronic.
