- Medtronic's Sphere-360™ catheter shows 88% freedom from arrhythmia recurrence at one year.
- Sphere-9™ catheter receives FDA approval; pivotal U.S. trials for Sphere-360 expected in 2025.
- Medtronic's Affera system expands global presence with innovative PFA technologies.
Medtronic (MDT, Financial), a leader in healthcare technology, announced positive outcomes from its clinical studies on atrial fibrillation (AFib) treatment utilizing the Affera™ family of technologies. The Sphere-360™ single-shot pulsed field ablation (PFA) catheter demonstrated robust performance in a one-year, prospective, multi-center trial, achieving 88% freedom from arrhythmia recurrence and 98% chronically durable pulmonary vein isolation. Notably, no serious safety events were reported in the optimized waveform group.
The Sphere-9™ catheter, which received FDA approval in October 2024, was effective for linear ablation in persistent AFib patients, according to sub-analysis from the Sphere Per-AF IDE study. Medtronic plans to initiate pivotal U.S. trials for the Sphere-360 catheter later this year, as it is currently investigational and not approved for sale or distribution globally.
The company's PFA solutions include the PulseSelect™ system, available in over 30 countries, and the Affera system with Sphere-9, accessible in Europe, Australia, and New Zealand. These tools address the progressive nature of AFib, which affects over 60 million people worldwide, significantly increasing the risks of heart failure, stroke, and death as the disease advances from paroxysmal to persistent forms.
