Medtronic’s Affera PFA Tech Shows Promise for AFib Patients

Medtronic announced positive outcomes from two atrial fibrillation (AFib) studies of patients treated with its Affera family of technologies.

These include the next-gen Sphere-360 single-shot pulsed field ablation (PFA) catheter and the Sphere-9 combination mapping and dual-energy focal PFA catheter.

Sphere-360 safety and performance

The investigational, single-shot PFA mapping and ablation catheter is for treating paroxysmal atrial fibrillation (PAF). Results from the trial showed freedom from arrhythmia occurrence in 88% of patients, with with chronically durable pulmonary vein isolation (PVI) in 98% of targeted veins.

There were no reported safety events in a sub-group treated with the most optimized waveform.

The Sphere-360 catheter has a large, conformable lattice design that can be modified into various shapes, is integrated with the Affera mapping and ablation system and uses an 8.5 Fr sheath—the smallest in any single-shot PFA technology, according to Medtronic.

“The Affera technology is a sophisticated ecosystem, including an advanced, intuitive mapping system and catheters that are seamlessly integrated to offer treatment options for different cardiac arrhythmias. It is encouraging to see the promising results for Sphere-360, which can easily create circumferential lesions without the need for catheter rotation,” said Vivek Reddy, MD, Director of Cardiac Arrhythmia Services for the Mount Sinai Health System in New York City. “The study results showed Sphere-360 has a promising safety and performance profile with zero serious adverse events observed. Upon approval, Sphere-360 will be a valuable addition to Medtronic’s Affera system, which has been a game changer for Afib treatment and physician workflow.”

Sphere-9 for linear ablation

Sphere Per-AF IDE study results showed the Sphere-9 catheter can be used to create linear lesions in persistent AFib patients. Linear ablation is often used with pulmonary vein isolation (PVI) to improve chances of restoring a normal heart rhythm without recurrence in persistent AFib patients.

The study evaluated Affera and Sphere-9 in persistent AFib and led to Affera’s FDA approval in October 2024.

“True to our Medtronic mission for patients and legacy of innovation, we are delivering our best-in-class technologies to physicians and improving care for AFib patients, and we are not slowing down,” said Rebecca Seidel, president of Medtronic’s Cardiac Ablation Solutions business. “These results signify another step forward and energize us as we continue to earn and build our leadership position in electrophysiology every day.”