Medical device company Medtronic has announced that it has received CE Mark approval for its Affera Mapping and Ablation System. The system, which includes the Sphere-9 Catheter and the Affera Prism-1 Mapping Software, provides a new paradigm in electrophysiology for the treatment of atrial arrhythmias, such as atrial fibrillation (AFib).
Atrial arrhythmias are a common condition affecting nearly 60 million people worldwide, with five million new patients being added each year. These conditions are associated with serious complications, including heart failure, stroke, and increased risk of death.
The Affera Mapping and Ablation System integrates Sphere-9 pulsed field ablation (PFA), radiofrequency (RF), and high-density (HD) mapping catheter to map and ablate atrial arrhythmias and provide real-time feedback through its intuitive mapping and navigation software. The all-in-one catheter’s nitinol 9mm ablation tip has the potential to reduce procedure times compared to standard irrigated ablation catheters, while the mapping software streamlines insights and feedback to support procedure performance.
Dr. Khaldoun Tarakji, vice president and chief medical officer of Cardiac Ablation Solutions business at Medtronic, believes the system represents a great advancement in the field of HD mapping and focal ablation. Current technologies require the use of separate HD mapping and ablation catheters, but the Sphere-9 Catheter eliminates the need to exchange catheters, empowering physicians to choose the energy source, whether RF or PFA, based on the patient’s needs. This, in turn, improves efficiency and safety during ablation procedures.
The Affera Mapping and Ablation System is supported by results from clinical studies assessing the safety and performance of the Sphere-9 Catheter and Mapping System. The CE Mark approval follows the completion of enrollment in the Affera SPHERE Per-AF Clinical Trial, a randomized, controlled U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) pivotal trial. This trial is designed to evaluate the safety and effectiveness of the Affera Mapping and Ablation System for the treatment of persistent atrial fibrillation and is currently in its 12-month follow-up phase.
Medtronic acquired Affera in August 2022, and the PulseSelect System, a novel single-shot and focal PF technology, is among the first to be brought to patients worldwide, according to Rebecca Seidel, president of Cardiac Ablation Solutions.
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’s CE Mark approval for the system represents a significant step forward in the treatment of atrial arrhythmias and the improvement of patient outcomes.
Medtronic’s Affera Mapping and Ablation System has received CE Mark approval, allowing for the treatment of atrial arrhythmias and improving efficiency and safety. The system integrates Sphere-9 pulsed field ablation (PFA), radiofrequency (RF), and high-density mapping catheter to map and ablate atrial arrhythmias and provide real-time feedback through its intuitive mapping and navigation software.