Medtronic has announced key clinical study milestones for its Affera Sphere-9 and Sphere-360 catheters, with the company reportedly receiving a breakthrough device designation from the FDA for the Sphere-9 catheter. The Sphere-360 catheter has received a CE mark in Europe and has begun its first US IDE cases to treat paroxysmal atrial fibrillation. Medtronic's Affera business appears to be gaining momentum globally, with these developments contributing to its continued adoption.