Devices

Medtronic’s Affera Mapping/Abalation Device Approved

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, 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.

Medtronic’s Affera Mapping/Abalation Device Approved

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome