Atrial fibrillation (AFib) is the most prevalent atrial arrhythmia globally, affecting approximately 60 million people worldwide. By 2030, an estimated five million more patients will be diagnosed each year. Atrial arrhythmias, including AFib, can lead to severe complications such as heart failure, stroke, and an increased risk of mortality. To address these challenges, the first-of-its-kind catheter with pulsed-field ablation, radiofrequency, and high-density mapping that is integrated with an intuitive mapping and navigation platform improves efficiency and enhances the safety of ablation procedures for patients.

The Affera Mapping and Ablation System from Medtronic plc (Dublin, Ireland), which includes the Sphere-9 Catheter and the Affera Prism-1 Mapping Software, marks a breakthrough in electrophysiology by integrating the Sphere-9 pulsed field ablation (PFA), radiofrequency (RF), and high density (HD) mapping catheter, which maps and ablates atrial arrhythmias (fast, abnormal heart rhythms) and provides real-time feedback using its intuitive mapping and navigation software.

The Sphere-9 Catheter, combined with the integrated mapping and navigation system, instantly generates sophisticated electro-anatomical maps, enabling physicians to administer wide-area focal ablation lesions of choice between RF or PFA, depending upon the requirements of the patient and procedure. Considering its size, the all-in-one catheter's nitinol 9mm ablation tip will need fewer focal ablation lesion applications that can reduce procedure times as compared to standard irrigated ablation catheters. The intuitive mapping software provides a highly optimized user experience by offering streamlined insights and feedback to support procedure performance.

Medtronic has received CE (Conformité Européenne) Mark for the Affera Mapping and Ablation System, based on results from clinical studies assessing the safety and performance of the Sphere-9 Catheter and Mapping System. The CE Mark approval comes on the back of the December 2022 announcement of the completion of enrollment for the Affera SPHERE Per-AF Clinical Trial, a randomized, controlled U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) pivotal trial. The SPHERE PER-AF IDE trial aims to investigate the safety and efficacy of the Affera Mapping and Ablation System in treating persistent atrial fibrillation. Currently, the trial is in its 12-month follow-up phase. The Affera Mapping and Ablation System will be available for commercial use in Europe by the first half of 2023, whereas it is still in the investigational stage in the U.S.

"The revolutionary Affera Mapping and Ablation System combined with the novel Sphere-9 Catheter represent a great advancement in the field of HD mapping and focal ablation," said Khaldoun Tarakji, M.D., MPH, vice president, chief medical officer, Cardiac Ablation Solutions business, which is part of the Cardiovascular Portfolio at Medtronic. "Current technologies require the use of separate HD mapping and ablation catheters. The ability to map, ablate, and validate with the Sphere-9 Catheter enables the physician to eliminate the need to exchange catheters and empowers them to choose the energy source, whether RF or PF, based on the patient's needs. All this leads to improving efficiency and most importantly, enhancing the safety of ablation procedures for our patients." 

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