Medtronic has received the US Food and Drug Administration (FDA) approval for its Affera Mapping and Ablation System with Sphere-9 Catheter.
Sphere-9 is an all-in-one solution for high-density (HD) mapping and pulsed field (PF) and radiofrequency (RF) ablation catheter. It is designed to treat persistent atrial fibrillation (AFib) and RF ablation of cavotricuspid isthmus (CTI) dependent atrial flutter.
With the approval, Medtronic is said to be the first and only company to offer two pulsed field ablation (PFA) technologies for patients with AFib.
The PulseSelect Pulsed Field Ablation System, approved by the FDA in December 2023, provides a single-shot solution for pulmonary vein isolation (PVI).
Medtronic acquired these technologies through the acquisition of Massachusetts-based Affera in August 2022.
Affera Sphere-9 catheter offers physicians treatment flexibility. Its wide area focal design and 9mm lattice tip can be used with an 8.5Fr sheath.
The catheter’s design allows physicians to deliver both PF and RF energy. It is fully integrated with the Affera Mapping and Ablation System.
This catheter improves workflow efficiency for physicians while ensuring safety and efficacy outcomes.
Medtronic cardiac ablation solutions engineering vice president and 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.
“This marks an exciting milestone for the field, with Medtronic’s robust innovation pipeline poised to drive continued progress.”
The FDA approval was based on strong results from the pivotal SPHERE Per-AF study, an Investigational Device Exemption (IDE) trial.
The trial compared the Sphere-9 catheter with the Affera Mapping and Ablation System to the conventional Thermocool SmartTouch SF radiofrequency ablation catheter using the Carto 3 System.
The Affera System, with the Sphere-9 catheter, received CE Mark approval in March 2023 and was approved in Australia in September 2024.
Earlier this month, the company announced the start of an early feasibility study to assess the Sphere-9 catheter for treating ventricular tachycardia (VT).
Earlier this week, Medtronic secured IDE approval for its Prevail coronary paclitaxel drug-coated balloon (DCB).
