Medtronic has announced FDA approval of its Affera Mapping and Ablation System with Sphere-9 Catheter, a novel tool for treating persistent atrial fibrillation (AFib) and cavotricuspid isthmus (CTI)-dependent atrial flutter. This all-in-one system integrates high-density mapping with both pulsed field (PF) and radiofrequency (RF) ablation capabilities.
The approval marks Medtronic as the first company to offer two PFA technologies for AFib, complementing their PulseSelect Pulsed Field Ablation System. The Sphere-9 catheter features a 9mm lattice tip, usable with an 8.5Fr sheath, providing physicians with a wide area focal design.
Clinical Validation and Design
The approval was supported by data from the SPHERE Per-AF study, which compared the Affera system to the Thermocool SmartTouch SF catheter with the Carto 3 System. The Sphere-9 catheter allows physicians to use either PF or RF energy, integrated with the Affera Mapping and Ablation System. Doron Harlev, VP of engineering at Medtronic, noted the system's design addresses procedural challenges while maintaining safety and efficacy.
Impact on Arrhythmia Treatment
Vivek Reddy, M.D., Director of Cardiac Arrhythmia Services for the Mount Sinai Health System, described the Affera system as a "game changer" for treating AFib and atrial flutter, praising its efficiency and short learning curve. The system aims to improve the treatment of a condition affecting over 60 million people globally.
Medtronic's Broader Strategy
Rebecca Seidel, president of Medtronic's Cardiac Ablation Solutions business, emphasized the company's commitment to addressing unmet patient needs through innovation. Medtronic also announced an early feasibility study to evaluate the Sphere-9 catheter for ventricular tachycardia (VT) treatment.
The Growing Burden of Atrial Fibrillation
AFib is a common heart rhythm disorder that can progress from intermittent (paroxysmal) to persistent. As the disease advances, the risk of complications like heart failure, stroke, and death increases. The Affera system represents a significant advancement in addressing this growing healthcare challenge.
