The Sphere-9 catheter offers physicians the option of both pulsed-field and radiofrequency energy delivery, fully integrated with the Affera Mapping and Ablation System.
Summary: Medtronic has received FDA approval for its Affera Mapping and Ablation System with the Sphere-9 catheter, which offers both pulsed-field and radiofrequency ablation for treating persistent atrial fibrillation and atrial flutter. This marks Medtronic’s second FDA-approved pulsed-field ablation technology. The approval was based on the positive results from the SPHERE Per-AF study, with the technology already gaining CE Mark and Australian approval.
Key Takeaways:
- FDA Approval of Sphere-9 Catheter: The Sphere-9 catheter, integrated with the Affera Mapping and Ablation System, allows for both pulsed-field and radiofrequency ablation, offering flexibility in treating atrial fibrillation and atrial flutter.
- Second Pulsed-Field Ablation Technology: This marks Medtronic’s second pulsed-field ablation system, following the FDA approval of PulseSelect in December 2023.
- Positive Study Results: The approval was based on favorable results from the SPHERE Per-AF study, comparing Sphere-9 to traditional ablation methods, and the technology has also gained approval in Europe and Australia.
Medtronic plc announced it has received United States Food and Drug Administration (FDA) approval of the Affera Mapping and Ablation System with Sphere-9 Catheter, an all-in-one, high-density mapping and pulsed-field and radiofrequency ablation catheter for treatment of persistent atrial fibrillation and for radiofrequency ablation of cavotricuspid isthmus dependent atrial flutter.
With this approval, Medtronic now has two pulsed-field ablation technologies available for patients with atrial fibrillation. The PulseSelect Pulsed Field Ablation System, which was FDA approved in December 2023, offers physicians a single-shot solution for pulmonary vein isolation, while the Affera Sphere-9 catheter enables physician treatment flexibility with its wide area focal design and 9mm lattice tip that can used with an 8.5Fr sheath.
“The significance of this innovative technology should be underscored; Affera is a game changer for treatment of Afib and atrial flutter,” says Vivek Reddy, MD, director of cardiac arrhythmia services for the Mount Sinai Health System in New York City, in a release. “The Affera system provides physicians with one safe, effective and efficient solution to this common and increasing problem in heart disease that needs optimized solutions for patients. With a short learning curve for experienced physicians, the possibilities are boundless for the treatment of Afib.”
Pulsed-Field and Radiofrequency Energy in One
The Sphere-9 catheter offers physicians the option of both pulsed-field and radiofrequency energy delivery, fully integrated with the Affera Mapping and Ablation System. The Sphere-9 catheter enhances workflow efficiency for physicians while providing excellent safety and efficacy outcomes.
“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,” says Doron Harlev, vice president of engineering for cardiac ablation solutions at Medtronic and founder of Affera, in a release.
Positive Clinical Trial Results
The approval was based on positive results demonstrated in the pivotal SPHERE Per-AF study, an FDA Investigational Device Exemption trial, which compared the Sphere-9 catheter with the Affera Mapping and Ablation System to the conventional Thermocool SmartTouch SF radiofrequency ablation catheter with the Carto3 System.
The Affera Mapping and Ablation System and Sphere-9 catheter also received CE Mark in March 2023 and was approved in Australia in September 2024.
In October 2024, Medtronic announced the start of an early feasibility study to evaluate the Sphere-9 catheter for treatment of ventricular tachycardia, a cardiac arrhythmia in which the lower chamber of the heart beats abnormally fast.
Photo caption: Affera Mapping and Ablation System with the Sphere-9 catheter
Photo credit: Medtronic
