Medtronic's Affera System with Sphere-9 Catheter Approved by FDA for Atrial Fibrillation Treatment
Key Insights
The FDA has approved Medtronic's Affera mapping and ablation system with the Sphere-9 Catheter (search) for treating persistent atrial fibrillation (search) and atrial flutter (search).
The Affera system (search) is the first to offer both pulsed-field and radiofrequency ablation, enhancing treatment flexibility for AFib patients.
The Sphere-9 catheter (search) integrates high-density mapping with both pulsed-field and radiofrequency ablation capabilities, improving workflow efficiency.
Medtronic has secured FDA approval for its Affera mapping and ablation system, which features the Sphere-9 Catheter (search), marking a significant advancement in the treatment of persistent atrial fibrillation (search) (AFib) and cavotricuspid isthmus (CTI)-dependent atrial flutter (search). This all-in-one system uniquely combines high-density (HD) mapping with both pulsed-field (PF) and radiofrequency (RF) ablation capabilities.
Dual PFA Technology
With this approval, Medtronic becomes the first company to offer two PFA technologies for AFib patients. The Affera Sphere-9 catheter (search) complements the previously approved PulseSelect pulsed field ablation system, providing physicians with a broader range of options for tailoring treatment to individual patient needs. The Sphere-9 catheter features a wide area focal design with a 9mm lattice tip and is compatible with an 8.5Fr sheath.
Innovative Design and Workflow
The Sphere-9 catheter (search) is designed for delivering both PF and RF energy, seamlessly integrating with the Affera mapping and ablation system. This design aims to improve workflow efficiency for electrophysiologists while maintaining high standards of safety and efficacy. According to Affera founder Doron Harlev, the system was developed to address procedural challenges in the electrophysiology community, offering a single transeptal, zero-fluoroscopy, and zero-exchange workflow.
Clinical Trial Data
The FDA's approval was based on data from the pivotal SPHERE Per-AF study, an FDA investigational device exemption (IDE) trial. This study compared the Sphere-9 catheter (search) to the conventional Thermocool SmartTouch SF radiofrequency ablation catheter used with the Carto*3 System. The Affera system (search) and Sphere-9 catheter also received CE Mark approval in March 2023 and authorization for use in Australia last month.
Ventricular Tachycardia Study
Medtronic has also initiated an early feasibility study to evaluate the Sphere-9 catheter (search) for treating ventricular tachycardia (search) (VT), a condition characterized by abnormally rapid heartbeats in the heart's lower chambers. This expansion of the Affera system (search)'s potential applications highlights Medtronic's commitment to addressing a range of cardiac rhythm disorders.
Impact of Atrial Fibrillation
Atrial fibrillation (search) affects over 60 million people worldwide and is a prevalent and often under-treated heart rhythm disorder. The disease is progressive, often starting as paroxysmal AFib (intermittent episodes) and potentially advancing to persistent AFib (episodes lasting more than seven days). The Affera system (search) offers a new approach to managing this condition with its integrated mapping and ablation technology.