Medtronic Earns FDA Approval for Affera Mapping and Ablation System & Sphere-9 Catheter

Medtronic has earned U.S. Food and Drug Administration (FDA) approval for its Affera mapping and ablation system with Sphere-9 catheter, an all-in-one, high-density mapping and pulsed field (PF) and radiofrequency (RF) ablation catheter.
 
The approval covers PF and RF ablation to treat persistent atrial fibrillation (AFib) and RF ablation to treat cavotricuspid isthmus (CTI) dependent atrial flutter. Medtronic is now the first, only company with two pulsed field ablation (PFA) technologies available for AFib patients.
 
The PulseSelect PFA system won FDA approval in December 2023. PulseSelect is a single-shot solution for pulmonary vein isolation (PVI), while the Affera Sphere-9 catheter offers treatment flexibility with a wide area focal design and 9 mm lattice tip that can be used with an 8.5 Fr sheath.
 
The approval was based on results demonstrated in the pivotal SPHERE Per-AF study, an FDA Investigational Device Exemption (IDE) trial, which compared the Sphere-9 catheter with the Affera mapping and ablation System to J&J MedTech’s conventional Thermocool SmartTouch SF radiofrequency ablation catheter with the Carto 3 system.
 
Affera and Sphere-9 catheter also received CE mark in March 2023 and was approved in Australia in September 2024. Earlier this month, Medtronic announced the start of an early feasibility study to evaluate the Sphere-9 catheter to treat ventricular tachycardia (VT).
 
“The Affera system was designed to address procedural challenges faced by the electrophysiology community while maintaining a high standard of safety and efficacy for patients. By enabling a single transeptal, zero-fluoroscopy, and zero-exchange workflow, the Sphere-9 catheter uniquely integrates both mapping and ablation technologies, offering the flexibility to use either pulsed field or radiofrequency energy,” said Doron Harlev, VP of engineering for Cardiac Ablation Solutions at Medtronic and founder of Affera. “This marks an exciting milestone for the field, with Medtronic’s robust innovation pipeline poised to drive continued progress.”
 
“At Medtronic, we have a 75-year tradition of bringing disruptive innovation to market, guided by our mission and commitment to address the unmet needs of patients. With the approval of Affera, we are excited to bring a novel mapping and ablation solution to clinicians that is intended to make atrial fibrillation treatment safer, more effective, and more efficient,” added Rebecca Seidel, president of Medtronic’s Cardiac Ablation Solutions business. “The potential of Affera is limitless. We will continue to fulfill our commitment to innovation, including new indications, to advance cardiovascular care and improve patient outcomes.”