Affera Mapping and Ablation System with Sphere-9 catheter achieves endpoints for safety and efficacy, providing promising evidence for the future of atrial fibrillation treatment – Medtronic

Medtronic plc , announced positive results demonstrating excellent safety and efficacy of the Affera Mapping and Ablation System with Sphere-9 Catheter, an all-in-one pulsed field (PF) and radiofrequency (RF) ablation and high density (HD) mapping catheter for the treatment of persistent atrial fibrillation (AFib). The SPHERE Per-AF study, FDA Investigational Device Exemption (IDE) pivotal trial, compared Sphere-9 to the conventional Thermocool SmartTouchSF radiofrequency ablation catheter with the Carto 3 System. Findings were presented as late-breaking clinical data at the Heart Rhythm Society (HRS) 2024 Annual Meeting and simultaneously published in Nature Medicine(opens new window).

“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 Elad Anter, M.D., Director of the Arrythmia Institute, Shamir Medical Center, Israel. “Persistent AFib patients make up 30-50% of the patient population and are often challenging to treat, with the majority of procedures requiring additional lesion sets beyond pulmonary vein isolation. The versatility and ease of use of this mapping and ablation system led to impressive efficiency and treatment outcomes in the trial.”

i. 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. ii. 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. iii. Treatment with the Sphere-9 catheter demonstrated superior efficiency over the control arm for procedural characteristics including: a. Skin-to-skin procedural time b. Time between first and last ablation. c.Energy application time. iv. 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 Rebecca Seidel, president, Cardiac Ablations Solutions business, which is part of the Cardiovascular Portfolio at Medtronic. “The Affera Mapping and Ablation system with Sphere-9 Catheter demonstrates a positive safety, efficacy and efficiency profile and can amplify our innovative and trusted portfolio. With these results, we are now one step closer to bringing this technology to the U.S. and beyond.”

<b 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: the United States, Czech Republic and Israel. All patients in both arms of the trial received pulmonary vein isolation as well as linear lesions based on the patient’s needs.

Affera Sphere-9 features include : a. All-in-one HD mapping and ablation catheter fully integrated with the Affera Mapping and Ablation System. b. 9mm lattice tip with large footprint. c.Convenience of dual energy, pulsed field or radiofrequency.

See-Anter, E., Mansour, M., Nair, D.G. et al.-” Dual-energy lattice-tip ablation system for persistent atrial fibrillation: a randomized trial”. Nat Med (2024). https://doi.org/10.1038/s41591-024-