Affera™ momentum grows with Medtronic obtaining CE Mark in Europe and U.S. IDE …

Medtronic’s advancements in the field of cardiovascular technology continue to gain momentum with the recent announcement of two significant milestones for the Affera™ Sphere-360™ catheter. This innovative catheter, designed for the treatment of paroxysmal atrial fibrillation (AFib), has received CE Mark in Europe and successfully completed the first cases in the Horizon 360 IDE pivotal trial in the United States.

The Sphere-360 catheter stands out as a rotation-free single-shot pulsed field ablation (PFA) catheter, making it a unique addition to the groundbreaking Affera family of technologies. Developed based on feedback from physicians, the catheter addresses the need for a straightforward workflow and predictable outcomes while accommodating anatomical variations in pulmonary veins. Integrated with the Affera mapping and ablation system, the catheter features an adjustable lattice design that conforms to vein shapes, allowing energy delivery without the need for catheter rotation at each position.

Physicians across various geographies have quickly embraced the Affera mapping and ablation system, as well as the Sphere-9™ all-in-one mapping and ablation catheter for their exceptional safety and durability profiles. Dr. Tobias Reichlin from Inselspital University Hospital in Switzerland commended the Sphere-360 catheter for delivering consistent, effective, and durable lesions for AFib patients without requiring catheter rotation. The seamless integration with the Affera mapping system represents a significant step forward in patient care in Europe.

The advantages of the Sphere-360 catheter include the ability to deliver circumferential, consistent lesions throughout the entire lattice without the need for catheter rotation, enhancing workflow efficiency. Its adaptability to vein shapes and an all-in-one design for navigation, mapping, and ablation provide added convenience during procedures. Real-time local impedance information aids in assessing catheter-tissue proximity, while the catheter’s design offers easy access to pulmonary veins with enhanced stability through an over-the-wire configuration.

Experts in the field, like Dr. Vivek Reddy from the Mount Sinai Health System in New York City, acknowledge the significant impact of recent advances in electrophysiology, with Affera playing a pivotal role. The introduction of Sphere-360, a rotation-free single-shot PFA catheter, represents the next phase of innovation in AFib treatment, promising new possibilities for both physicians and patients. The European study on Sphere-360, presented at the Heart Rhythm Society Annual Meeting and published in the Heart Rhythm Journal in April 2025, demonstrated excellent efficacy, safety, and durability that led to CE Mark approval.

The attainment of CE Mark for Sphere-360 and the commencement of the U.S. IDE trial mark major milestones in Medtronic’s commitment to delivering enhanced treatments for AFib patients. The ongoing Horizon 360 IDE study in the U.S. aims to evaluate the safety and effectiveness of the Sphere-360 catheter with the Affera mapping and ablation system for treating paroxysmal AFib.

Medtronic’s innovative solutions in the field of pulsed field ablation include the PulseSelect™ Pulsed Field Ablation System, offering a safe, single-shot solution for pulmonary vein isolation in over 35 countries. Additionally, Sphere-9™ serves as an all-in-one dual-energy mapping and ablation catheter for persistent AFib and CTI-dependent atrial flutter. With its global approval and ongoing expansion, the Affera system continues to offer physicians treatment flexibility and cutting-edge technology for improved patient outcomes.