A new paradigm in electrophysiology: Medtronic receives FDA approval of Affera™ Mapping and Ablation System and Sphere-9™ Catheter

Core Insights - Medtronic has received FDA approval for the Affera Sphere-9 catheter, making it the first company to offer two PFA technologies for patients with atrial fibrillation (Afib) [1][2] - The Sphere-9 catheter integrates both mapping and ablation technologies, allowing for a single transeptal, zero-fluoroscopy, and zero-exchange workflow, enhancing procedural efficiency [2][3] - The Affera system aims to improve the safety, efficacy, and efficiency of Afib treatment, addressing the unmet needs of over 60 million people affected by this condition globally [3] Group 1: Product Details - The PulseSelect™ Pulsed Field Ablation System was FDA approved in December 2023, providing a single-shot solution for pulmonary vein isolation [1] - The Sphere-9 catheter features a 9mm lattice tip and can be used with an 8.5Fr sheath, offering flexibility in treatment options [1] - The Sphere-9 catheter allows for both pulsed field and radiofrequency energy delivery, fully integrated with the Affera Mapping and Ablation System [2] Group 2: Clinical Significance - The approval was based on positive results from the pivotal SPHERE Per-AF study, which compared the Sphere-9 catheter to conventional radiofrequency ablation methods [2] - The Affera Mapping and Ablation System received CE Mark in March 2023 and was approved in Australia in September 2024, indicating its international recognition [2] - Medtronic plans to evaluate the Sphere-9 catheter for treating ventricular tachycardia (VT) in an early feasibility study starting in October 2024 [2] Group 3: Company Commitment - Medtronic emphasizes its 75-year tradition of innovation aimed at addressing patient needs, with the Affera system representing a significant advancement in cardiovascular care [3] - The company is committed to ongoing innovation and expanding indications to improve patient outcomes in the field of cardiac health [3] - Medtronic's global team of over 95,000 employees is dedicated to developing technologies that transform healthcare and improve lives [5]