Medtronic plc announced significant advancements in atrial fibrillation (AFib) treatment with promising clinical trial results for its latest pulsed field ablation (PFA) technologies, aiming to enhance patient outcomes globally.
Sphere-360™ Catheter Demonstrates Exceptional Performance
In a one-year prospective study conducted across multiple European centers, the investigational Sphere-360™ single-shot PFA catheter achieved an 88% rate of freedom from arrhythmia recurrence in patients with paroxysmal AFib. Additionally, the device maintained pulmonary vein isolation in 98% of targeted veins, with no safety events reported in a subgroup receiving the most refined waveform settings.
Dr. Vivek Reddy highlighted the Sphere-360’s adaptable lattice design and seamless integration with the Affera Mapping and Ablation System as key factors contributing to its success. The catheter’s ability to form circumferential lesions without requiring rotation marks a significant improvement in ease of use and efficacy.
Sphere-9™ Catheter Shows Efficacy in Persistent AFib
Further reinforcing Medtronic’s leadership, the Sphere-9™ combination mapping and dual-energy focal PFA catheter displayed effective results in linear ablation for persistent AFib patients within the Sphere Per-AF IDE study. These findings supported the FDA’s approval of the Affera system in October 2024, expanding treatment options for complex arrhythmia cases.
Rebecca Seidel, president of Cardiac Ablation Solutions at Medtronic, emphasized the company’s relentless pursuit of innovation, stating that these results advance their position in electrophysiology and reaffirm their commitment to improving AFib care.
Key takeaways include:
- High arrhythmia freedom (88%) with Sphere-360 demonstrates strong efficacy.
- 98% durable pulmonary vein isolation suggests lasting treatment effects.
- No serious adverse events in optimized settings ensure patient safety.
- Sphere-9’s success in linear ablation offers effective solutions for persistent AFib.
Medtronic’s continued innovation in AFib treatment solutions underscores the company’s dedication to improving cardiovascular therapy. These advancements not only offer physicians effective tools for managing complex arrhythmias but also promise enhanced quality of life for patients. As Sphere-360 moves towards the U.S. pivotal trial and global availability expands, the medical community anticipates broader adoption of these technologies, potentially setting new standards in AFib management.
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