Medtronic has announced FDA approval for 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 uniquely 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 existing PulseSelect Pulsed Field Ablation System. The Sphere-9 catheter features a 9mm lattice tip and can be used with an 8.5Fr sheath, providing physicians with flexibility in treating a range of AFib cases.
Clinical Validation and Expert Opinion
The FDA's decision was supported by data from the SPHERE Per-AF study, which compared the Affera system to the Thermocool SmartTouch SF radiofrequency ablation catheter with the Carto system. The Affera system also received CE Mark approval in March 2023 and approval in Australia in September 2024.
"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," said Vivek Reddy, M.D., Director of Cardiac Arrhythmia Services for the Mount Sinai Health System in New York City.
Technology and Workflow
The Sphere-9 catheter's design allows physicians to choose between PF and RF energy delivery, integrated within the Affera Mapping and Ablation System. This integration aims to streamline workflow by enabling a single transeptal, zero-fluoroscopy, and zero-exchange procedure.
"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.
Market Context and Disease Burden
AFib affects over 60 million people globally and is associated with increased risks of heart failure, stroke, and death. The Affera system represents a new option in the electrophysiology space, potentially improving treatment outcomes and procedural efficiency.
Medtronic has also initiated an early feasibility study to explore the Sphere-9 catheter's use in treating ventricular tachycardia (VT), further expanding its potential applications.
