SHERIDAN, WYOMING – May 5, 2025 – Medtronic plc (NYSE: MDT) has announced encouraging one-year clinical outcomes for its investigational Affera™ pulsed field ablation (PFA) technologies, reinforcing its strategic leadership in arrhythmia management. The results—revealed at the Heart Rhythm Society 2025 Annual Meeting—highlight the performance of the next-generation Sphere-360™ single-shot PFA catheter and the dual-energy Sphere-9™ catheter in treating patients with paroxysmal and persistent atrial fibrillation (AFib), one of the world’s most prevalent cardiac rhythm disorders.
Sphere-360™ Demonstrates Safety, Efficiency, and Superior Mapping Integration
The Sphere-360 catheter, part of the Affera ecosystem, is engineered as a single-shot PFA mapping and ablation tool designed specifically for paroxysmal AFib. In a European-based, multi-center clinical trial, the technology achieved:
- 88% freedom from arrhythmia recurrence at one year
- 98% durable pulmonary vein isolation (PVI) in targeted veins
- Zero serious adverse events in patients treated with the most optimized waveform
The Sphere-360 catheter features a large, shape-modifiable lattice tip and integrates seamlessly with the Affera Mapping and Ablation System. Notably, it operates through an 8.5 Fr sheath—currently the smallest of its kind for single-shot PFA applications.
“The Affera technology is a sophisticated ecosystem… It is encouraging to see the promising results for Sphere-360, which can easily create circumferential lesions without the need for catheter rotation,” stated Dr. Vivek Reddy, Director of Cardiac Arrhythmia Services at Mount Sinai Health System, New York. “The study results showed Sphere-360 has a promising safety and performance profile with zero serious adverse events observed.”
With plans for a pivotal U.S. trial later this year, Sphere-360 represents a critical step in expanding Medtronic’s PFA offerings across global markets. Currently, the device remains investigational and not available for commercial use.
Sphere-9™ Enables Effective Linear Ablation in Persistent AFib Patients
In parallel, Medtronic also shared compelling findings from a sub-analysis of the Sphere Per-AF IDE study, evaluating the dual-energy Sphere-9 catheter. Designed for persistent AFib, the Sphere-9 demonstrated:
- Reliable formation of linear ablation lesions
- Safe, efficient integration with PVI strategies to reduce AFib recurrence
These results follow the U.S. FDA’s 2024 approval of the Affera system, underscoring Medtronic’s continued momentum in delivering integrated, dual-energy technologies for electrophysiologists treating advanced arrhythmias.
Expanding Market Reach and Physician Treatment Flexibility
Medtronic remains the only company offering two distinct pulsed field ablation systems:
- PulseSelect™: A commercially available, single-shot PFA system for PVI across 30+ countries
- Affera with Sphere-9™: A focal dual-energy platform with a 9mm lattice tip, compatible with the same minimal 8.5 Fr sheath
Both platforms are strategically positioned to meet evolving clinical needs across multiple geographies, with Affera currently available in Europe, Australia, and New Zealand, and broader global expansion in progress.
AFib Innovation Amidst Global Health Challenges
Atrial fibrillation affects over 60 million people globally, yet it remains significantly underdiagnosed and undertreated. As the condition progresses from paroxysmal to persistent stages, the risk of heart failure, stroke, and death increases markedly.
Through the Affera ecosystem and PFA portfolio, Medtronic is advancing meaningful clinical innovation to address this global health burden.
“True to our Medtronic mission… we are delivering our best-in-class technologies to physicians and improving care for AFib patients, and we are not slowing down,” emphasized Rebecca Seidel, president of Medtronic’s Cardiac Ablation Solutions business.
Learn more about Medtronic’s Affera PFA solutions at www.medtronic.com.