FDA approves mapping, dual-energy catheter ablation system for persistent AF
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Key takeaways:
- The FDA approved a mapping and dual-energy catheter ablation system for treatment of persistent AF.
- The system is designed to deliver both radiofrequency and pulsed field ablation.
Medtronic announced the FDA approval of its mapping and dual-energy catheter ablation system for the treatment of persistent atrial fibrillation and radiofrequency ablation of cavotricuspid isthmus-dependent atrial flutter.
The mapping and catheter ablation system (Affera mapping and ablation system with Sphere-9 catheter) is designed with a wide area focal design and a 9 mm lattice tip that can used with an 8.5 French sheath and can deliver both radiofrequency and pulsed field ablation, according to a company press release.
The approval was based on the results of the pivotal, noninferiority SPHERE Per-AF trial, in which 420 patients with symptomatic persistent AF (mean age, 67 years; 68% men) were randomly assigned to ablation with the all-in-one mapping system or conventional radiofrequency ablation system (Thermocool SmartTouch SF radiofrequency ablation catheter with Carto navigation and mapping system, Biosense Webster).
As Healio previously reported, the mapping and dual-energy catheter ablation system was noninferior vs. the conventional radiofrequency ablation system for treatment of persistent AF.
“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,” Doron Harlev, vice president of engineering for cardiac ablation solutions at Medtronic and founder of Affera, said in the release. “This marks an exciting milestone for the field, with Medtronic’s robust innovation pipeline poised to drive continued progress.”
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