Medtronic’s Affera Mapping and Ablation System Receives CE Mark for the Treatment of Atrial Arrhythmias
- The company has received CE mark clearance for its Affera mapping & ablation system incl. the Sphere-9 catheter & Affera Prism-1 mapping software to treat atrial arrhythmias or fast, abnormal heart rhythms. The company plans to commercially launch the Affera system in the EU in H1’23 & is investigational in the US
- The system integrates Sphere-9 pulsed-field ablation (PFA), radiofrequency, and high-density mapping. It maps and ablates atrial arrhythmias incl. AFib provides real-time feedback through its mapping and navigation software
- The IDE pivotal trial (SPHERE Per-AF Trial) evaluates the safety & effectiveness of the Affera Mapping & Ablation System for treating persistent AF while the trial is currently in 12mos. follow up phase
Ref: Medtronic | Image: Medtronic
Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at email@example.com.