Affera received CE mark more than a year ago. In January, CEO Geoff Martha reported “good progress” in bringing the Affera Sphere-9 PFA mapping and ablation catheter to the U.S. market this year. Medtronic recently filed for FDA approval for the system in the U.S. (It features on MassDevice’s list of medical devices to watch for in 2024).
The all-in-one pulsed field (PF) and radiofrequency (RF) ablation and high-density (HD) mapping catheter treats persistent AFib. Medtronic’s SPHERE Per-AF study, an FDA IDE pivotal trial, compared it to the Biosense Webster Thermocool SmartTouch SF ablation system with Carto 3 mapping.
Investigators presented the data at the Heart Rhythm Society today and simultaneously published the results in Nature Medicine.
Dr. Elad Anter, director of the Arrythmia Institute, Shamir Medical Center, Israel, called the results “excellent” for the investigational system. Anter said the data demonstrated the ability of the Sphere-9 lattice tip to create a wide circumferential pulmonary vein isolation. This demonstrated the ability to ablate lesions in a safe, effective and efficient manner through versatile means.
“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 Dr. Vivek Reddy, 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.”
A look at the data from Medtronic
The prospective, multi-center trial randomized subjects 1:1 to receive either Sphere-9 treatment or Thermocool SmartTouch treatment. It enrolled 420 patients across 23 sites in the U.S., Czech Republic and Isreal. All patients in both arms received pulmonary vein isolation and linear lesions based on their needs.
Sphere-9 demonstrated a positive safety profile, reaching a primary safety endpoint rate of 1.4%. The study saw no safety events, including pulmonary vein stenosis, esophageal events or cardiac tamponade. More than 95% of Sphere-9 procedures used a single transeptal puncture, compared to 62% in the control arm.
Medtronic said Sphere-9 delivered 73.8% freedom from AFib compared to 65.8% in the control arm. After 100% acute isolation of pulmonary veins and linear lesions, Sphere-9 patients also saw less recurrence of atrial arrhythmias through one year of follow-up. Sphere-9 treatment also demonstrated superior efficiency over the control for a number of procedural characteristics. That included skin-to-skin procedural time, time between first and last ablation and energy application time.
According to Medtronic, patients treated with Sphere-9 experienced quality-of-life 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 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.”
