Affera™ Mapping and Ablation System Now in Use in Sweden, More Nordic Countries to Follow Soon

Affera™ Mapping and Ablation System Now in Use in Sweden, More Nordic Countries to Follow Soon

The Affera™ Mapping and Ablation System, including the Sphere-9™ Catheter and the Affera™ Prism-1 Mapping Software, is now in clinical use for the first time in Sweden. More Nordic countries will follow soon. This advanced system, which maps and ablates atrial arrhythmias (fast, abnormal heart rhythms), provides real-time feedback through intuitive mapping and navigation software, marking a significant step forward in cardiac care across the Nordics.

Supported by results from clinical studies assessing the safety and performance of the Sphere-9 Catheter and Mapping System, the Affera Mapping and Ablation System received CE Mark in March 2023. On April 16, 12-month findings of the EU study to support the CE Mark for the Affera Mapping and Ablation System were published in JACC: Electrophysiology, demonstrating that the Sphere™-9 Catheter can successfully treat patients with either paroxysmal or persistent atrial fibrillation (AF) in an efficient, safe, and clinically efficacious manner using a variety of ablation lesion sets.

AF affects more than 60 million people worldwide. Persistent AF occurs when symptoms last for more than seven days and do not resolve on their own. Paroxysmal AF episodes last from a few seconds to days but stop spontaneously. Without early intervention, AF can progress¹ and is associated with a higher rate of cardiovascular admissions², heart failure hospitalization³, and mortality⁴, along with a reduced quality of life⁵. There are three common methods to treat AF – medication, cardioversion, or a catheter ablation procedure.

Treatment with the Sphere-9 Catheter provided 85% one-year freedom from recurrence of atrial arrhythmias in patients receiving the PULSE³ waveform (the optimized, commercial Affera System pulsed field waveform). In all paroxysmal and persistent AF patients who underwent an ablation, 78% of both cohorts remained free from all atrial arrhythmias at the conclusion of the study. The study achieved its primary safety endpoint of 0.6%, including zero incidences of atrio-esophageal fistula, coronary spasm, pulmonary vein stenosis, and phrenic nerve injury.

Medtronic is currently the only MedTech company able to provide this unique system, reinforcing its commitment to delivering groundbreaking solutions for cardiac arrhythmia treatment. The Affera™ Mapping and Ablation System will soon be introduced in additional Nordic countries, expanding access to this innovative technology.

To learn more about the Medtronic Affera Mapping and Ablation System and available treatment options, visit Medtronic.com.

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References:

1. Chugh SS, et al. Worldwide Epidemiology of Atrial Fibrillation. Circulation. 2014;129:837-847. https://pubmed.ncbi.nlm.nih.gov/31955707//

1. de Vos CB et al. Progression from paroxysmal to persistent atrial fibrillation clinical correlates and prognosis. J Am Coll Cardiol. 2010;55(8):725-731.

1. Wong JA et al. Progression of Device-Detected Subclinical Atrial Fibrillation and the Risk of Heart Failure. J Am Coll Cardiol. 2018;71(23):2603-2611.

1. Piccini JP et al. Atrial fibrillation burden, progression, and the risk of death: a case-crossover analysis in patients with cardiac implantable electronic devices. Europace. 2019;21(3):404-413.

1. Dudink E et al. The influence of progression of atrial fibrillation on quality of life: a report from the Euro Heart Survey, EP Europace, Volume 20, Issue 6, June 2018, Pages 929–934.