First, the medtech giant received CE mark approval for the first-of-its-kind, all-in-one mapping and single-shot PFA catheter. It also completed the first cases for the paroxysmal AFib treatment system in the Horizon 360 U.S. FDA investigational device exemption (IDE) trial.
It marks further milestones for Medtronic as it competes in the hot PFA space against the likes of Boston Scientific, Johnson & Johnson MedTech, Abbott and Kardium, all of whom have commercially available PFA systems.
“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 the Cardiac Ablation Solutions business at Medtronic. “We’re committed to leading in PFA and bringing meaningful innovation at a regular cadence.”
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Sphere-360, an investigational single-shot mapping and ablation catheter, uses pulsed field energy to treat patients with paroxysmal AFib. It integrates with the Affera mapping and ablation system. The Affera technology makes up a key component of Medtronic’s PulseSelect PFA system. It became the first such system FDA-cleared for treating AFib in 2024. Medtronic brought in these technologies through its $1 billion acquisition of Affera in August 2022.
Medtronic designed Sphere-360 with the goal of simplifying the AFib procedure while enhancing efficiency and providing high lesion durability. Sphere-360 features a large, tissue-conformable lattice tip for energy delivery. It requires no catheter rotation multiple times in one location as the entire lattice tip delivers PF energy. The company says it features the smallest sheath (8.5 Fr) in any single-shot PFA technology.
Other key features include the delivery of circumferential, consistent lesions and adaptation to the vein through the lattice tip. The all-in-one catheter can deliver navigation, mapping and ablation through a single transseptal puncture and zero catheter exchange. It provides easy access to pulmonary veins and enhanced stability with its over-the-wire design, too.
Medtronic supported its CE mark with data from its Sphere-360 European study, presented in April 2025. Findings demonstrated efficacy, safety and durability for the system.
The Horizon 360 IDE study, a prospective, single-arm clinical study across the U.S., will evaluate the safety and effectiveness of the Sphere-360 catheter with the Affera mapping and ablation system for treating paroxysmal AFib.
Doctors’ takes on the Medtronic Sphere-360 catheter
Dr. Tobias Reichlin, 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.”
Dr. Vivek Reddy, director of Cardiac Arrhythmia Services for the Mount Sinai Health System, New York, said:
“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.”
