FDA approval for Affera mapping and ablation system with Sphere-9 catheter for treatment of persistent atrial fibrillation

With this approval, Medtronic is now the first and only company with two PFA technologies available for patients with Afib. The PulseSelect Pulsed Field Ablation System, which was FDA approved in December 2023, offers physicians a safe, single-shot solution for pulmonary vein isolation (PVI) 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," said Vivek Reddy, M.D., Director of Cardiac Arrhythmia Services for the Mount Sinai Health System in New York City. "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."

With a trailblazing design, the Sphere-9 catheter offers physicians the option of both PF and RF 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," said Doron Harlev, vice president 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."

The approval was based on excellent 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 the conventional Thermocool SmartTouch SF radiofrequency ablation catheter with the Carto 3 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 (VT), a cardiac arrhythmia in which the lower chamber of the heart beats abnormally fast.

AFib is one of the most common and undertreated heart rhythm disorders, affecting more than 60 million people worldwide.. Afib is a progressive disease, often beginning as paroxsymal AFib (presents intermittently) and progressing to persistent (lasts for more than 7+ days without stopping). As the disease progresses, the risk of serious complications including heart failure, stroke and risk of death increases.