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# Medtronic’s Affera Mapping/Abalation Device Approved
- URL: https://www.fdaweb.com/medtronics-affera-mapping-abalation-device-approved/
- Published: 2024-10-25T12:00:00.000Z
- Updated: 2026-09-14T14:45:06.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5158056

FDA has approved Medtronic’s Affera Mapping and Ablation System with Sphere-9 Catheter, which it describes as a mapping and pulsed-field radiofrequency ablation catheter for treating persistent atrial fibrillation and cavotricuspid isthmus-dependent atrial flutter.

The device was designed to address “procedural challenges faced by the electrophysiology community,” the company says. “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.”

Approval was based on data from the pivotal [SPHERE Per-AF study](https://c212.net/c/link/?t=0&l=en&o=4286798-1&h=3289627108&u=https%3A%2F%2Fnews.medtronic.com%2F2024-05-17-Medtronic-Affera-TM-Mapping-and-Ablation-System-with-Sphere-9-TM-Catheter-achieves-endpoints-for-safety-and-efficacy%2C-providing-promising-evidence-for-the-future-of-atrial-fibrillation-treatment&a=SPHERE+Per-AF+study&ref=fdaweb.com), which compared the Sphere-9 catheter with the Affera Mapping and Ablation System to Johnson & Johnson’s conventional Thermocool SmartTouch SF radiofrequency ablation catheter with the Carto 3 System.