Medtronic Presents New Clinical Data for Ablation Systems
The company shared registry results for its Affera and PulseSelect systems at the APHRS 2026 scientific meeting.
Updated on Oct. 24, 2026 in Heart Disease
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Medtronic released new clinical registry data regarding the safety and efficacy of its Affera Mapping and Ablation System and PulseSelect PFA System. The analysis examined performance across large patient cohorts globally.
Why it matters
These registry results provide significant performance data for pulsed field ablation technologies used to treat atrial fibrillation and ventricular tachycardia. Demonstrating both high acute success and low complication rates is critical for the validation of these cardiac procedures.
The REAL PULSE registry reported a 100% acute success rate across 1,160 atrial fibrillation patients. Additionally, the European APEX registry analysis for ventricular tachycardia indicated an 87% acute success rate among 46 patients.
The players
Medtronic
Medtronic is a global medical device company headquartered in Galway, Ireland, that develops technologies for cardiovascular, neurological, and surgical applications.
The details
The REAL PULSE registry analysis included 1,160 patients across 38 sites, while the APEX analysis tracked 1,050 patients at 28 sites globally. Researchers also evaluated the Sphere-9 catheter, which combines high-definition mapping with both pulsed field and radiofrequency ablation.
Timeline
Results were presented on October 24, 2026, at the APHRS scientific meeting.
The Big Picture
This reporting follows the pattern set by the APHRS 2026 scientific meeting for disseminating clinical outcomes. Such data updates are essential for bridging the gap between innovative ablation research and standardized clinical practice.
These findings offer clearer safety metrics for patients considering minimally invasive ablation procedures for atrial fibrillation. However, since the Sphere-9 catheter remains investigational for ventricular tachycardia in the United States, patients should consult with specialists regarding current local approvals.
The takeaway
These findings highlight the growing efficacy and safety profiles of pulsed field ablation systems in cardiac care. Medical providers and patients should monitor the investigational status of specific catheter tools as they move through regulatory processes.
Further reading
Find more context on current developments in Heart Disease.
Source note: This article includes information reported by Pharmabiz.
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