Medtronic plc, a global leader in healthcare technology, has officially published positive results to prove excellent safety and efficacy of the Affera™ Mapping and Ablation System with Sphere-9™ Catheter. In case you weren’t aware, the technology in question is an all-in-one pulsed field (PF) and radiofrequency (RF) ablation and high density (HD) mapping catheter meant to be used for the treatment of persistent atrial fibrillation (AFib). Anyway, the stated results were achieved on the back of SPHERE Per-AF study, a U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) pivotal trial, where Sphere-9 was compared to the conventional Thermocool SmartTouch® SF radiofrequency ablation catheter with the Carto™ 3 System. Talk about these findings on a slightly deeper level, they reflected how the device in question demonstrated a positive safety profile, boasting an excellent primary safety endpoint rate of 1.4% (1.0% for the control arm). Having reported no negative consequences whatsoever, more than 95% of Sphere-9 procedures were also found to use a single transeptal puncture, as compared to 62% in the control arm. Next up, we must dig into the fact that, throughout the trial, Sphere-9 demonstrated 73.8% freedom from AFib vs. only 65.8% observed in the control arm. Furthermore, after 100% acute isolation of pulmonary veins and linear lesions, patients treated with the Sphere-9 Catheter reported less recurrence of atrial arrhythmias during the 12-month follow up period.
“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, a part of Medtronic’s Cardiovascular Portfolio. “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.”
Another detail worth a mention here would be how treatment done using the Sphere-9 catheter achieved superior efficiency over the control arm for procedural characteristics like skin-to-skin procedural time, time between first and last ablation, and energy application time. Finally, patients who were treated through the Sphere-9 catheter experienced improvements to quality of life in the context of both their mental and physical well-being.
All in all, SPHERE Per-AF was a prospective, multicenter, randomized clinical trial, randomized 1:1 to receive treatment. Working with over 420 subjects, the study saw participants coming from 23 different sites across three countries i.e. United States, Czech Republic, and Israel.
With its efficiency clearly proven, we can round things up by discussing some key features of Medtronic’s Sphere-9 device. For instance, we can acknowledge its all-in-one HD mapping and ablation catheter, which is made to fully integrate with the Affera Mapping and Ablation System. Then, there is a lattice tip bearing a large footprint, sizing up to be around 9mm. On top of that, users can also come expecting the sheer 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 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.”
