Medtronic Gains US FDA Nod for AFib Mapping and Ablation System

Medtronic plc, a prominent player in healthcare technology worldwide, revealed that the FDA has given the green light for the Affera Mapping and Ablation System with Sphere-9 catheter, a comprehensive HD mapping and PF/RF ablation catheter for treating persistent AFib and CTI-dependent atrial flutter.

Having received this approval, Medtronic is now the sole company offering two PFA technologies for Afib patients. The PulseSelect Pulsed Field Ablation System, approved by the US FDA in December 2023, provides doctors with a secure method for pulmonary vein isolation (PVI), while the Affera Sphere-9 catheter gives physicians treatment flexibility due to its broad area focal design and 9 mm lattice tip that can be utilized with an 8.5Fr sheath.

“The significance of this innovative technology should be underscored; Affera is a game changer for treatment of Afib and atrial flutter,” said Vivek Reddy, director of cardiac arrhythmia services for the Mount Sinai Health System in New York City. “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.”

Featuring an innovative design, the Sphere-9 catheter provides doctors with the choice of delivering both PF and RF energy, seamlessly connected to the Affera Mapping and Ablation System. The Sphere-9 catheter improves the efficiency of workflow for doctors, all while maintaining excellent safety and effectiveness results.