Medtronic receives CE Mark for the Affera Mapping and Ablation System

Medtronic announced that it has received CE, or Conformite Europeenne, Mark for the Affera Mapping and Ablation System, which includes the Sphere-9 Catheter and the Affera Prism-1 Mapping Software. Together, the full system creates a new paradigm in electrophysiology through the unique integration of the Sphere-9 pulsed field ablation, or PFA, radiofrequency, or RF, and high density, or HD, mapping catheter, which maps and ablates atrial arrhythmias and provides real-time feedback through its intuitive mapping and navigation software. Atrial fibrillation, or AFib, is the most common atrial arrhythmia, and nearly 60 million people are affected worldwide1 and five million patients will be added every year by 20302. Atrial arrhythmias, such as AFib, are associated with serious complications including heart failure, stroke and increased risk of death3-6. The Sphere-9 Catheter, coupled with the integrated mapping and navigation system, quickly generates sophisticated electro-anatomical maps allowing the physician to deliver wide-area focal ablation lesions of choice between RF or PFA, based on the patient and procedure needs. The Affera Mapping and Ablation System will be commercially available beginning in the first half of 2023 in Europe and is investigational in the United States. Medtronic acquired Affera in August 2022. Worldwide, the PulseSelect System is investigational and not approved for sale or distribution.