Medtronic said that its Affera Mapping and Ablation System with Sphere-9 Catheter has achieved the safety and efficacy endpoints in the SPHERE Per-AF trial in patients with persistent atrial fibrillation (AFib).
Sphere-9 Catheter is an all-in-one pulsed field (PF) and radiofrequency (RF) ablation and high density (HD) mapping catheter.
The SPHERE Per-AF study compared Sphere-9 with the traditional Thermocool SmartTouch SF radiofrequency ablation catheter along with the Carto 3 System.
Medtronic had received an investigational device exemption (IDE) from the US Food and Drug Administration (FDA) for the trial.
The prospective, multicentre trial assessed 420 patients across three countries over 12 months for the primary analysis. The study randomised them to receive either Sphere-9 or Thermocool SmartTouch SF catheter.
According to the results, the Sphere-9 Catheter showed an excellent primary safety endpoint rate of 1.4% with no major safety events. Over 95% of the patients used a single transeptal puncture, compared to 62% in the control arm.
Sphere-9 showcased 73.8% freedom from AFib against 65.8% observed in the control arm. In addition, patients treated with the Sphere-9 Catheter saw less atrial arrhythmia recurrence post-100% acute isolation of pulmonary veins and linear lesions.
Besides, the Sphere-9 treatment showed superior efficiency in terms of procedural characteristics and enhanced patient quality of life.
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 medical device company has recently submitted an application to the FDA for seeking approval of the Affera Sphere-9 Catheter.
In a separate development, Medtronic has published positive data on its investigational OmniaSecure defibrillation.
As per the findings, the small-diameter defibrillation lead met its primary safety and effectiveness endpoints, surpassing prespecified performance goals, in the Lead Evaluation for Defibrillation and Reliability (LEADR) trial.
The primary efficacy and safety results showed that defibrillation testing succeeded in 97.5% of 119 patients, surpassing the 88% goal.
At six months, 97.1% of 657 patients remained free from major lead-related complications, which exceeded the 90% target.
The medical device company intends to share additional reliability model findings from the LEADR trial in the upcoming months.
