The Affera system features the first-of-its-kind, all-in-one HD-mapping and dual energy ablation catheter Sphere-9. Credit: Medtronic.

Medtronic has announced that the US Food and Drug Administration (FDA) has approved the Affera mapping and ablation system featuring the Sphere-9 Catheter.

This innovative, all-in-one system combines high-density (HD) mapping with pulsed-field (PF) and radiofrequency (RF) ablation capabilities for the treatment of persistent atrial fibrillation (AFib) and RF ablation of cavotricuspid isthmus (CTI)-dependent atrial flutter.

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With this approval, Medtronic becomes the first and only company to offer two PFA technologies for AFib patients. The previously FDA-approved PulseSelect pulsed field ablation system provides a safe, single-shot solution for pulmonary vein isolation (PVI). The Affera Sphere-9 catheter enhances treatment flexibility with its wide area focal design and 9mm lattice tip, compatible with an 8.5Fr sheath.

The Sphere-9 catheter is designed for both PF and RF energy delivery, seamlessly integrated with the Affera mapping and ablation system. This innovative design improves workflow efficiency for physicians while ensuring safety and efficacy outcomes.

Affera founder Doron Harlev said: “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.

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“This marks an exciting milestone for the field, with Medtronic’s robust innovation pipeline poised to drive continued progress.”

The approval is based on the positive results from the pivotal SPHERE Per-AF study, an FDA investigational device exemption (IDE) trial that compared the Sphere-9 catheter with the conventional Thermocool SmartTouch SF radiofrequency ablation catheter used with the Carto*3 System.

The Affera mapping and ablation system and Sphere-9 catheter also got CE Mark approval in March 2023 and were authorised for use in Australia last month.

This month, Medtronic announced the initiation of an early feasibility study to assess the Sphere-9 catheter for the treatment of ventricular tachycardia (VT), a condition characterised by abnormal rapid heartbeats in the heart’s lower chambers.

Impacting more than 60 million people worldwide, AFib is one of the most prevalent and under-treated heart rhythm disorders. It is a progressive disease that often starts as paroxysmal AFib (intermittent episodes) and can progress to persistent AFib (lasting more than seven days without stopping).