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Medtronic completes enrollment in pulsed-field ablation catheter trial

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Medtronic’s Sphere-9 mapping and ablation catheter [Photo courtesy of Medtronic]
Medtronic today announced it completed enrollment and final treatment in the Sphere Per-AF pivotal trial to study Affera’s pulsed-field ablation catheter tech.

The trial is evaluating the safety and effectiveness of the Sphere-9. The Sphere-9 is a pulsed field (PF) and radio frequency (RF) ablation and high-density mapping catheter. Along with the Affera cardiac mapping and navigation platform, it treats atrial fibrillation.

Affera designed the technology to diagnose, map and treat heart arrhythmias with ablation. It scars heart tissue to interrupt errant signals using both radiofrequency ablation and non-thermal pulsed-field ablation technology. Medtronic acquired the company for $1 billion in August.

Get the full story on our sister site, Medical Tubing + Extrusion.

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About Danielle Kirsh

Danielle Kirsh is an award-winning journalist and senior editor for Medical Design & Outsourcing, MassDevice, and Medical Tubing + Extrusion, and the founder of Women in Medtech and lead editor for Big 100. She received her bachelor's degree in broadcast journalism and mass communication from Norfolk State University and is pursuing her master's in global strategic communications at the University of Florida. You can connect with her on Twitter and LinkedIn, or email her at [email protected].