Medtronic has announced positive results from the SPHERE Per-AF trial, which evaluated the efficacy and safety of the Affera Mapping and Ablation System with Sphere-9 Catheter for treating persistent atrial fibrillation (AFib).
The trial met its primary safety and efficacy endpoints, demonstrating the potential of this all-in-one pulsed field (PF) and radiofrequency (RF) ablation and high-density (HD) mapping catheter system.
A pivotal trial under the US Food and Drug Administration’s (FDA) Investigational Device Exemption (IDE), the SPHERE Per-AF study compared the Sphere-9 Catheter to the conventional Thermocool SmartTouch SF radiofrequency ablation catheter with the Carto 3 System.
The Sphere-9 Catheter showcased a positive safety profile with a primary safety endpoint rate of 1.4%, which was comparable to the control arm's rate of 1%.
The trial noted that more than 95% of procedures using the Sphere-9 Catheter required only a single transeptal puncture, against 62% in the control arm.
This catheter also showed 73.8% freedom from AFib, surpassing the 65.8% observed in the control arm.
Patients treated with the Sphere-9 Catheter experienced fewer recurrences of atrial arrhythmias over a 12-month follow-up period.
The device also showed superior efficiency in procedural characteristics such as skin-to-skin procedural time, time between first and last ablation, and energy application time.
Additionally, patients reported improvements in both mental and physical quality of life after treatment with the Sphere-9 Catheter.
The SPHERE Per-AF trial was a prospective, multi-centre, randomised clinical trial that enrolled 420 patients across 23 sites in the US, Czech Republic, and Israel.
The Affera Sphere-9 Catheter features a 9mm lattice tip and the convenience of dual-energy options, pulsed-field or radiofrequency.
Medtronic Cardiovascular Portfolio’s cardiac ablations solutions business president Rebecca Seidel said: “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 US and beyond.”
The Affera Mapping and Ablation System received CE Mark approval in March 2023 and the Affera Sphere-9 Catheter is currently under FDA review for approval in the US. It is not yet approved for sale or distribution.
