Medtronic’s next-generation Affera technologies strengthen innovation in atrial fibrillation care
Find out how Medtronic’s Affera™ system is redefining atrial fibrillation care with breakthrough pulsed field ablation technologies. Read the full update!
Medtronic plc has reinforced its leadership in cardiac electrophysiology with the latest clinical results for its investigational Affera™ pulsed field ablation (PFA) technologies, showcased at the 2025 Heart Rhythm Society Annual Meeting in San Diego. The one-year data for the Sphere-360™ single-shot PFA catheter and Sphere-9™ dual-energy focal PFA catheter demonstrate strong safety, impressive performance, and promising efficiency for patients with paroxysmal and persistent atrial fibrillation (AFib).
In an era where atrial fibrillation remains one of the most pervasive yet undertreated heart rhythm disorders, affecting over 60 million people globally, Medtronic’s innovations aim to address a growing need for effective, safer ablation therapies. AFib often progresses from intermittent, or paroxysmal, presentations to more chronic persistent forms, increasing risks of stroke, heart failure, and mortality as the disease advances.
What Did the Sphere-360™ Trial Reveal About AFib Treatment?
The Sphere-360™ is Medtronic’s next-generation single-shot PFA catheter, featuring an adaptable lattice design capable of reshaping during procedures, integrated with the Affera Mapping and Ablation System. In a prospective, single-arm, multi-center European clinical trial, Sphere-360 demonstrated arrhythmia-free survival in 88% of treated patients at one year. Notably, pulmonary vein isolation (PVI) durability was achieved in 98% of targeted veins, and no serious adverse events were recorded within the subgroup treated with the most optimized energy waveform.

The device utilizes an 8.5 French sheath — the smallest in the single-shot PFA segment — marking a significant advancement in procedural efficiency. Physicians appreciated the ability of Sphere-360 to create circumferential lesions without catheter rotation, streamlining workflows in electrophysiology labs.
According to Dr. Vivek Reddy, Director of Cardiac Arrhythmia Services at the Mount Sinai Health System, the Affera technology ecosystem, integrating advanced mapping and ablation capabilities, represents a transformative step forward in arrhythmia management. Dr. Reddy noted that the Sphere-360 results are encouraging, particularly the absence of any serious adverse events, which positions it as a valuable addition once regulatory approvals are secured.
Medtronic confirmed its plans to initiate a pivotal U.S. clinical trial for Sphere-360 later in 2025, while globally, the catheter remains investigational and not yet commercially available.
How Is Sphere-9™ Redefining Linear Ablation for Persistent AFib?
Beyond paroxysmal AFib management, Medtronic’s Sphere-9™ dual-energy focal PFA catheter demonstrated efficacy for linear ablation in persistent AFib patients, based on a sub-analysis from the Sphere Per-AF IDE study. Linear ablation, used alongside PVI, enhances the chances of restoring normal heart rhythms in more advanced stages of AFib.
The Sphere Per-AF IDE study underpinned the U.S. Food and Drug Administration’s 2024 approval of the Affera system, underscoring its safety, efficacy, and procedural efficiency. The Sphere-9 catheter, with its 9mm lattice tip design and compatibility with an 8.5 Fr sheath, offers wide-area focal ablation, enhancing physician control and patient outcomes.
Rebecca Seidel, President of Cardiac Ablation Solutions at Medtronic, highlighted the company’s commitment to pioneering electrophysiology solutions that prioritize both patient care and physician needs. She emphasized that Medtronic remains energized by these clinical successes, which solidify its expanding leadership in arrhythmia management technologies.
Why Is Medtronic’s Dual-Platform Strategy Significant for Electrophysiology?
Currently, Medtronic stands as the only company offering two distinct PFA technologies for AFib treatment: the PulseSelect™ Pulsed Field Ablation System and the Affera platform with Sphere-9™ catheter integration.
PulseSelect, available in over 30 countries, provides a safe, single-shot solution specifically focused on pulmonary vein isolation. Meanwhile, the Affera system offers flexible wide-area focal ablation for more complex arrhythmia cases, especially persistent AFib. With approvals already in Europe, Australia, and New Zealand, Medtronic is actively expanding Affera’s global footprint, catering to an increasing demand for advanced electrophysiology solutions.
This dual-platform approach positions Medtronic advantageously in a highly competitive and fast-growing PFA market segment. Industry analysts suggest that Medtronic’s emphasis on innovation, procedural flexibility, and clinical outcomes could further strengthen its market share in cardiac ablation technologies, where the demand for safe, effective, and fast ablation is rising sharply.
How Is Medtronic Stock Reacting to Recent Clinical Developments?
Medtronic plc (NYSE: MDT) has seen a cautious but positive investor sentiment surrounding its cardiac innovations. Following the Heart Rhythm Society announcements, institutional investor flows indicated moderate buying interest, reflecting growing confidence in Medtronic’s cardiac electrophysiology pipeline.
Analysts tracking the stock view the Sphere-360 and Sphere-9 results as additive to Medtronic’s long-term growth prospects, particularly in light of the multi-billion dollar market opportunity for PFA systems. While broader medical device sector performance remains sensitive to regulatory timelines and healthcare spending cycles, Medtronic’s diversified portfolio across cardiovascular, diabetes, and surgical robotics provides a stabilizing effect.
At the time of writing, Medtronic shares are trading steadily, with sentiment classified as “Moderately Positive.” Buy-side recommendations have edged higher, with consensus targets suggesting a moderate upside from current levels.
How Are Advancements Like Sphere-360™ and Sphere-9™ Reshaping AFib Treatment?
The advent of PFA technologies, particularly Medtronic’s Affera suite, is changing the therapeutic landscape for AFib patients. Pulsed field ablation offers tissue-selective ablation with minimal collateral damage compared to traditional thermal ablation methods, translating into potentially safer procedures with faster recovery times.
Medtronic’s Sphere-360, with its lattice catheter design, and Sphere-9’s wide-area focal capabilities are engineered to enhance procedural consistency, reduce complexity, and elevate the overall efficacy of AFib treatments. These innovations not only advance the clinical management of arrhythmias but also improve physician workflow, hospital resource utilization, and ultimately patient outcomes.
AFib’s prevalence is projected to increase in the coming decades due to aging populations and rising comorbidity burdens such as hypertension and diabetes. Consequently, next-generation technologies like those from Medtronic are critical for healthcare systems aiming to manage this epidemic efficiently and effectively.
As Medtronic continues its commitment to bold innovation, the integration of these new technologies into global cardiac care standards appears increasingly likely. The company’s latest clinical achievements provide both immediate momentum and long-term strategic advantage in the rapidly evolving field of arrhythmia management.
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