'These are excellent results for the investigational Sphere-9 catheter. The data show Sphere-9 lattice tip technology enables physicians to create a wide circumferential pulmonary vein isolation, which is the cornerstone of any type of AFib ablation, and any set of desired ablation lesions, in a safe, effective and efficient manner,' said
The Sphere-9 Catheter demonstrated a positive safety profile with an excellent primary safety endpoint rate of 1.4% (1.0% for the control arm). Importantly, no safety events including pulmonary vein stenosis, esophageal events or cardiac tamponade were reported. More than 95% of Sphere-9 procedures used a single transeptal puncture compared to 62% in the control arm.
Sphere-9 demonstrated 73.8% freedom from AFib* vs. only 65.8% observed in the control arm. Following 100% acute isolation of pulmonary veins and linear lesions, patients treated with the Sphere-9 Catheter also observed less recurrence of atrial arrhythmias throughout the 12-month follow up period.
Treatment with the Sphere-9 catheter demonstrated superior efficiency over the control arm for procedural characteristics including:
Skin-to-skin procedural time
Time between first and last ablation
Energy application time
Patients treated with the Sphere-9 catheter experienced improvements to quality of life in both mental and physical well-being.
'As pioneers in cardiac ablation treatment, including cryoablation and PFA, we are thrilled to share these results providing excellent evidence for use of this all-in-one catheter that can be used with no need to pull a second catheter,' said
SPHERE Per-AF was a prospective, multicenter, randomized clinical trial evaluating the Sphere-9 Catheter with the Affera Mapping and Ablation System for treatment of persistent AFib. Subjects were randomized 1:1 to receive treatment with either the Sphere-9 Catheter with the Affera Mapping and Ablation System or the Thermocool SmartTouch SF radiofrequency ablation catheter with the Carto 3 System. For the primary analysis, a total of 420 patients were enrolled across 23 sites in three countries:
Affera Sphere-9 features include:
All-in-one HD mapping and ablation catheter fully integrated with the Affera Mapping and Ablation System
9mm lattice tip with large footprint
Convenience of dual energy, pulsed field or radiofrequency
'We've been waiting for one catheter that can be used for every arrhythmia, and these randomized results from centers that routinely use conventional point by point ablation indicate Affera Sphere-9 will be worth the wait with all its innovation and the rapid learning curve of the system,' said
The company recently filed for approval of the Affera Sphere-9 Catheter in the
AFib is one of the most common and undertreated heart rhythm disorders, affecting more than 60 million people worldwide.1 Afib is a progressive disease, often beginning as paroxsymal AFib (presents intermittently) and progressing to persistent (lasts for more than 7+ days without stopping). As the disease progresses, the risk of serious complications including heart failure, stroke and risk of death increases2-5.
For more information on Affera SPHERE-9, visit Medtronic.com.
*The primary effectiveness endpoint was a composite of freedom from: failure to isolate all targeted pulmonary veins and complete all left atrial ablation with the assigned study device; repeat ablation at any time after the index procedure; and after a 3-month blanking period, documented occurrence of atrial tachyarrhythmia, escalation or initiation of Class I or III antiarrhythmic drugs, or cardioversion.
About Medtronic
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References
Roth GA, Mensah GA, Johnson CO et al. Global Burden of Cardiovascular Diseases and Risk Factors, 1990-2019: Update From the GBD 2019 Study. J Am Coll Cardiol 2020;76:2982-3021.
Miyasaka Y, Barnes ME, Bailey KR, et al. Mortality trends in patients diagnosed with first atrial fibrillation: a 21-year community-based study. J Am Coll Cardiol 2007;49:986-92.
Hindricks G, Potpara T, Dagres N, et al. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the
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