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 provides high-density mapping and dual-energy ablation (pulsed field and radiofrequency) capabilities.
Dual-Energy Ablation System
The Sphere-9 catheter's design allows physicians to choose between pulsed field (PF) and radiofrequency (RF) energy delivery, integrated with the Affera Mapping and Ablation System. The 9mm lattice tip of the Sphere-9 catheter can be used with an 8.5Fr sheath.
With this approval, Medtronic is the first company to offer two PFA technologies for Afib. The PulseSelect Pulsed Field Ablation System, approved in December 2023, provides a single-shot solution for pulmonary vein isolation (PVI), while the Affera Sphere-9 catheter offers treatment flexibility with its wide area focal design.
Clinical Trial Data
The FDA's approval was based on data from the SPHERE Per-AF study, which compared the Sphere-9 catheter with the Affera Mapping and Ablation System to the Thermocool SmartTouch SF radiofrequency ablation catheter with the Carto system. The Affera system had previously received CE Mark approval in March 2023 and was approved in Australia in September 2024.
Physician Perspective
"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.
Ventricular Tachycardia Study
Medtronic has also initiated an early feasibility study to evaluate the Sphere-9 catheter for treating ventricular tachycardia (VT), a cardiac arrhythmia characterized by an abnormally fast heart rate in the lower chambers of the heart.
Addressing a Critical Need
AFib affects over 60 million people worldwide and is associated with increased risks of heart failure, stroke, and death. The Affera system aims to improve the safety, efficacy, and efficiency of AFib treatment.
Company Statement
"With the approval of Affera, we are excited to bring a novel mapping and ablation solution to clinicians that is intended to make atrial fibrillation treatment safer, more effective, and more efficient," said Rebecca Seidel, president of the Cardiac Ablation Solutions business at Medtronic. "The potential of Affera is limitless. We will continue to fulfill our commitment to innovation, including new indications, to advance cardiovascular care and improve patient outcomes."
