Galway, Ireland & Chicago, Illinois | April 25, 2026

Medtronic has announced significant clinical milestones for its Affera™ mapping and ablation system, highlighting strong data for the Sphere-9™ and Sphere-360™ catheters presented at the Heart Rhythm Society (HRS) 2026 Annual Meeting. The findings underscore advancements in treating complex cardiac arrhythmias, including ventricular tachycardia (VT) and atrial fibrillation (AFib), reinforcing Medtronic’s leadership in next-generation cardiac ablation technologies.

Sphere-9 Catheter Demonstrates Promising VT Outcomes

Late-breaking results from an early feasibility study evaluating the Sphere-9™ catheter revealed that 65.5% of patients remained free from ventricular tachycardia recurrence at six months, a significant improvement in a condition known for its high morbidity and mortality risk. VT, a life-threatening arrhythmia often associated with prior heart attacks, remains challenging to treat due to limited innovation in ablation tools and suboptimal clinical outcomes.

The Sphere-9 catheter integrates dual-energy capabilities, combining pulsed field (PF) and radiofrequency (RF) ablation with high-definition mapping, enabling physicians to deliver precise and efficient therapy. Recognizing its potential, the U.S. Food and Drug Administration (FDA) has granted the technology Breakthrough Device Designation, facilitating an accelerated regulatory pathway and highlighting its importance in addressing critical unmet clinical needs.

This innovation is particularly relevant as healthcare providers seek safer, more effective ablation techniques that can improve procedural success rates while minimizing complications, positioning Sphere-9 as a transformative tool in electrophysiology.

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Sphere-360 Catheter Shows High Durability Across AFib Cases

Complementing these findings, new data from the Sphere-360™ catheter demonstrated exceptional lesion durability in atrial fibrillation procedures, with 100% durability observed in patients with complex anatomical variations, such as left common pulmonary veins. Previous results also showed 98% per vein and 93% per patient durability, confirming consistent performance across diverse patient populations.

The Sphere-360 catheter, a single-shot pulsed field ablation system, is designed to simplify procedures while maintaining high precision and reproducibility. Its CE Mark approval in Europe and ongoing U.S. investigational trials reflect growing confidence in its ability to enhance procedural efficiency and long-term outcomes.

Physicians have noted that the system’s ease of use and adaptability contribute to improved workflow and reduced procedure times, aligning with the broader industry trend toward minimally invasive, high-efficiency cardiac interventions.

Expanding Clinical Research and Global Adoption

Medtronic also announced the enrollment of the first patient in the Conquer-AF trial, a global, multi-center study evaluating the Sphere-9 catheter in patients with recurrent AFib who have previously undergone ablation procedures. This trial aims to generate robust clinical evidence across a broader patient population, further strengthening the case for widespread adoption of the Affera system.

The company’s ongoing investment in clinical research reflects its commitment to advancing safe, effective, and scalable solutions for cardiac rhythm disorders. With approvals already secured in multiple global markets and continued expansion of its clinical pipeline, Medtronic is well-positioned to drive innovation in electrophysiology and improve patient outcomes worldwide.

These developments highlight a broader shift toward integrated mapping and ablation platforms, where precision, versatility, and data-driven insights play a central role in treatment success. As arrhythmias such as AFib and VT continue to affect millions globally, the need for next-generation technologies that deliver durable and reliable outcomes remains critical.

By combining cutting-edge engineering, clinical validation, and global scalability, the Affera system represents a significant step forward in addressing the complexities of cardiac arrhythmia treatment, ultimately contributing to improved quality of life and reduced healthcare burden.

Source: Medtronic press release