Medtronic has announced US Food and Drug Administration (FDA) approval of the Affera mapping and ablation system with Sphere-9 Catheter, an all-in-one, high-density (HD) mapping and pulsed field (PF) and radiofrequency (RF) ablation catheter for treatment of persistent atrial fibrillation (AF) and for RF ablation of cavotricuspid isthmus (CTI) dependent atrial flutter.
With this approval, Medtronic says it is the first and only company with two PFA technologies available for patients with AF. The PulseSelect system, which was FDA approved in December 2023, offering a single-shot solution for pulmonary vein isolation (PVI) while the Affera Sphere-9 catheter enables physician treatment flexibility with its wide area focal design and 9mm lattice tip that can used with an 8.5Fr sheath.
“The significance of this innovative technology should be underscored; Affera is a game changer for treatment of AF and atrial flutter,” said Vivek Reddy (Mount Sinai Health System, New York, USA). “The Affera system provides physicians with one safe, effective and efficient solution to this common and increasing problem in heart disease that needs optimised solutions for patients. With a short learning curve for experienced physicians, the possibilities are boundless for the treatment of AF.”
The Sphere-9 catheter offers physicians the option of both PF and RF energy delivery, integrated with the Affera mapping and ablation system. The Sphere-9 catheter enhances workflow efficiency for physicians while providing excellent safety and efficacy outcomes.
“The Affera system was designed to address procedural challenges faced by the electrophysiology community while maintaining a high standard of safety and efficacy for patients. By enabling a single transseptal, 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. “This marks an exciting milestone for the field, with Medtronic’s robust innovation pipeline poised to drive continued progress.”
The approval was based on results from the pivotal SPHERE Per-AF study, an FDA investigational device exemption (IDE) trial, which compared the Sphere-9 catheter with the Affera mapping and ablation system to the conventional Thermocool SmartTouch SF radiofrequency ablation catheter with the Carto3 system (Biosense Webster).
The Affera mapping and ablation system and Sphere-9 catheter also received CE mark in March 2023 and was approved in Australia in September 2024. In October 2024, Medtronic announced the start of an early feasibility study to evaluate the Sphere-9 catheter for treatment of ventricular tachycardia (VT).
“At Medtronic, we have a 75-year tradition of bringing disruptive innovation to market, guided by our mission and commitment to address the unmet needs of patients. 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, which is part of the Medtronic Cardiovascular Portfolio. “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.”
