Medtronic plc (NYSE: MDT), a global leader in healthcare technology,  announced positive results demonstrating the excellent safety and efficacy of the Affera™ Mapping and Ablation System with Sphere-9™ Catheter. This all-in-one pulsed field (PF) and radiofrequency (RF) ablation and high-density (HD) mapping catheter is designed for the treatment of persistent atrial fibrillation (AFib). The SPHERE Per-AF study, a pivotal trial under the U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE), compared Sphere-9 to the conventional Thermocool SmartTouch® SF 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.

"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 Arrhythmia 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."

Key Study Findings:

• Safety Profile: Sphere-9 Catheter demonstrated an excellent primary safety endpoint rate of 1.4% (1.0% for the control arm). No safety events, including pulmonary vein stenosis, esophageal events, or cardiac tamponade, were reported.
• Procedural Efficiency: More than 95% of Sphere-9 procedures used a single transeptal puncture compared to 62% in the control arm.
• Effectiveness: Sphere-9 demonstrated 73.8% freedom from AFib* vs. 65.8% in the control arm. Patients treated with Sphere-9 also observed less recurrence of atrial arrhythmias throughout the 12-month follow-up period.
• Quality of Life: Patients experienced improvements 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 of the Cardiac Ablations Solutions business, 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."

Study Details:

SPHERE Per-AF was a prospective, multicenter, randomized clinical trial evaluating the Sphere-9 Catheter with the Affera Mapping and Ablation System for treating 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, 420 patients were enrolled across 23 sites in the United States, Czech Republic, and Israel. All patients in both arms received pulmonary vein isolation as well as linear lesions based on their needs.

Affera Sphere-9 Features:

• All-in-one HD mapping and ablation catheter integrated with the Affera Mapping and Ablation System
• 9mm lattice tip with a large footprint
• Dual energy options: 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 Vivek Reddy, M.D., Director of Cardiac Arrhythmia Services for the Mount Sinai Health System in New York City. "These are important, highly anticipated results and groundbreaking news for the electrophysiology community that could change the treatment workflow."

The company recently filed for approval of the Affera Sphere-9 Catheter in the U.S. with the FDA. The Affera Sphere-9 Catheter is investigational in the United States and not approved for sale or distribution. The Affera Mapping and Ablation System, including the Sphere-9 Catheter, received CE Mark approval in March 2023.

AFib is one of the most common and undertreated heart rhythm disorders, affecting more than 60 million people worldwide. AFib is a progressive disease, often beginning as paroxysmal AFib (presents intermittently) and progressing to persistent (lasts for more than seven days without stopping). As the disease progresses, the risk of serious complications, including heart failure, stroke, and risk of death, increases.