Medtronic has secured FDA approval for its Affera Mapping and Ablation System with the Sphere-9 Catheter, marking a significant advancement in the treatment of persistent atrial fibrillation (AFib) and cavotricuspid isthmus (CTI) dependent atrial flutter. This all-in-one system integrates high-density mapping with both pulsed field (PF) and radiofrequency (RF) ablation capabilities.
The Sphere-9 catheter, designed for use with an 8.5Fr sheath, features a 9mm lattice tip and offers physicians the flexibility to choose between PF and RF energy delivery. This integrated approach aims to improve workflow efficiency while maintaining high standards of safety and efficacy.
According to Dr. Vivek Reddy, Director of Cardiac Arrhythmia Services for the Mount Sinai Health System, the Affera system presents "one safe, effective and efficient solution to this common and increasing problem in heart disease." He also noted the system's short learning curve for experienced physicians.
The FDA's approval was based on data from the SPHERE Per-AF study, a pivotal IDE trial that compared the Affera system with the Sphere-9 catheter to the Thermocool SmartTouch SF radiofrequency ablation catheter using the Carto 3 System. The study demonstrated the safety and efficacy of the Affera system in treating atrial fibrillation.
Doron Harlev, vice president of engineering for Cardiac Ablation Solutions at Medtronic and founder of Affera, stated that the system was designed to address procedural challenges in electrophysiology. The Sphere-9 catheter allows for a single transeptal, zero-fluoroscopy, and zero-exchange workflow, integrating mapping and ablation technologies with the option of pulsed field or radiofrequency energy.
Rebecca Seidel, president of the Cardiac Ablation Solutions business at Medtronic, expressed excitement about bringing this novel solution to clinicians, with the goal of making AFib treatment safer, more effective, and more efficient. She also emphasized Medtronic's commitment to innovation in cardiovascular care.
