Sam Brusco, Associate Editor05.20.24
Medtronic released data showing the safety and efficacy of its Affera mapping and ablation system with the Sphere-9 catheter.
The all-in-one pulsed field (PF) and radiofrequency (RF) ablation and high density (HD) mapping catheter treats persistent atrial fibrillation (AFib). The company’s SPHERE Per-AF study, a U.S. Food and Drug Administration (FDA) investigational device exemption (IDE) pivotal trial, compared it to Biosense Webster’s Thermocool SmartTouch SF RF ablation catheter with Carto 3 mapping.
Medtronic’s Affera earned CE mark clearance more than a year ago and said it recently filed for U.S. Food and Drug Administration (FDA) approval for it. The company acquired the technology in 2022.
The late-breaking clinical data was presented at the Heart Rhythm Society 2024 annual meeting and simultaneously published in the journal 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 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."
Sphere-9 showed a positive safety profile with a primary safety endpoint rate of 1.4% and no safety events of pulmonary vein stenosis, esophageal events, or cardiac tamponade. Over 95% of Sphere-9 procedures used a single transseptal puncture, compared to 62% in the control arm.
Medtronic also said Sphere-9 demonstrated 73.8% freedom from AFib vs. 65.8% in the control arm. After 100% acute isolation of pulmonary veins and linear lesions, Sphere-9 patients also had less recurrence of atrial arrythmias throughout the 12-month follow-up period. Superior efficiency over the control arm was also seen for characteristics like skin-to-skin procedure time, time between the first and last ablation, and energy application time. Sphere-9 patients also reports 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 of Medtronic’s Cardiac Ablations Solutions business. "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."
The all-in-one pulsed field (PF) and radiofrequency (RF) ablation and high density (HD) mapping catheter treats persistent atrial fibrillation (AFib). The company’s SPHERE Per-AF study, a U.S. Food and Drug Administration (FDA) investigational device exemption (IDE) pivotal trial, compared it to Biosense Webster’s Thermocool SmartTouch SF RF ablation catheter with Carto 3 mapping.
Medtronic’s Affera earned CE mark clearance more than a year ago and said it recently filed for U.S. Food and Drug Administration (FDA) approval for it. The company acquired the technology in 2022.
The late-breaking clinical data was presented at the Heart Rhythm Society 2024 annual meeting and simultaneously published in the journal 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 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."
More on the data from Medtronic
The SPHERE Per-AF was a multicenter, randomized clinical trial where patients were 1:1 randomized to either receive Sphere-9 catheter with Affera or the Thermocool SmartTouch. 420 patients were enrolled across 23 sites in the U.S., Czech Republic, or Israel. All of the patients in both trial arms received pulmonary vein isolation and linear lesions based on the patient’s needs.Sphere-9 showed a positive safety profile with a primary safety endpoint rate of 1.4% and no safety events of pulmonary vein stenosis, esophageal events, or cardiac tamponade. Over 95% of Sphere-9 procedures used a single transseptal puncture, compared to 62% in the control arm.
Medtronic also said Sphere-9 demonstrated 73.8% freedom from AFib vs. 65.8% in the control arm. After 100% acute isolation of pulmonary veins and linear lesions, Sphere-9 patients also had less recurrence of atrial arrythmias throughout the 12-month follow-up period. Superior efficiency over the control arm was also seen for characteristics like skin-to-skin procedure time, time between the first and last ablation, and energy application time. Sphere-9 patients also reports 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 of Medtronic’s Cardiac Ablations Solutions business. "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."