Medtronic plc, a global leader in healthcare technology, has announced encouraging clinical outcomes from two significant studies involving atrial fibrillation (AFib) patients. These studies focus on the Affera family of technologies, particularly the Sphere-360 single-shot pulsed field ablation (PFA) catheter and the Sphere-9 combination mapping and dual-energy focal PFA catheter. The data unveiled during the Heart Rhythm Society 2025 Annual Meeting in San Diego underscores Medtronic’s commitment to advancing arrhythmia management solutions.
The Sphere-360 Study, which is a prospective, single-arm, multi-center trial conducted in European centers, revealed that 88% of patients experienced freedom from arrhythmia recurrence at the one-year mark. Additionally, the study demonstrated that 98% of targeted veins achieved chronically durable pulmonary vein isolation (PVI). Importantly, no safety events were reported in a subgroup treated with an optimized waveform. The Sphere-360 catheter, characterized by its large and conformable lattice design, integrates seamlessly with the Affera Mapping and Ablation System and employs an 8.5 Fr sheath, marking it as the smallest in any single-shot PFA technology.
Vivek Reddy, M.D., Director of Cardiac Arrhythmia Services at the Mount Sinai Health System in New York City, expressed optimism about the results, highlighting the catheter’s ability to create circumferential lesions effortlessly. He emphasized the promising safety and performance profile of the Sphere-360, which registered zero serious adverse events. Upon approval, this catheter is expected to enhance Medtronic’s Affera system, which has already made significant strides in AFib treatment and physician workflow.
Medtronic is preparing to initiate its U.S. pivotal trial for the Sphere-360 catheter later this year. Currently, the Sphere-360 remains investigational and is not approved for sale or distribution worldwide.
The Sphere-9 catheter, as part of a sub-analysis from the Sphere Per-AF IDE study, has shown efficacy and safety in creating linear lesions for persistent AF patients. Linear ablation, often used alongside PVI, plays a crucial role in restoring normal heart rhythm and reducing recurrence risks in persistent AF patients. The Sphere Per-AF IDE study evaluated the Affera and Sphere-9 systems’ safety, efficacy, and efficiency in persistent AF, culminating in the FDA’s approval of Affera in October 2024.
Rebecca Seidel, president of the Cardiac Ablation Solutions business at Medtronic, expressed the company’s dedication to innovation and improving care for AFib patients. She noted that these results are a testament to Medtronic’s commitment to maintaining its leadership in electrophysiology.
Medtronic stands out as the only company offering two PFA solutions for physicians and patients. The PulseSelect Pulsed Field Ablation System, providing a safe, single-shot solution for PVI, is now available in over 30 countries. The Affera system, combined with the Sphere-9 catheter, offers treatment flexibility with its wide-area focal design and 9mm lattice tip, compatible with an 8.5Fr sheath. Currently, Affera is accessible in Europe, Australia, and New Zealand, with ongoing global expansion efforts.
AFib remains one of the most common and undertreated heart rhythm disorders, affecting over 60 million individuals worldwide. The condition often progresses from paroxysmal AFib, which occurs intermittently, to persistent AFib, lasting more than seven days without cessation. As AFib advances, the risk of severe complications, such as heart failure, stroke, and death, increases significantly.
For more insights into the Affera PFA system and the Sphere-9 catheter, visit Medtronic’s official website.
Note: This article is inspired by content from https://www.prnewswire.com/news-releases/medtronic-affera-pulsed-field-ablation-technologies-continue-to-demonstrate-promising-evidence-for-atrial-fibrillation-patients-302439006.html. It has been rephrased for originality. Images are credited to the original source.