Medtronic has completed participant enrolment and final treatment in the SPHERE Per-AF Trial of its Sphere-9 pulsed field (PF) and radiofrequency (RF) ablation and mapping catheter for atrial fibrillation (AF) patients.
The multicentre, prospective, randomised, global clinical trial has been designed to evaluate the effectiveness and safety of the first-of-its-kind Sphere-9 cardiac ablation and mapping catheter with the Affera mapping and navigation system in the treatment of persistent AF patients.
Since the start of the trial last December, 477 persistent AF patients across 23 centres in the US and Europe have been enrolled in the US Food and Drug Administration (FDA) Investigational Device Exemption (IDE) pivotal trial.
The participants will be evaluated for 12 months for safety and efficacy.
Medtronic Cardiovascular Portfolio Cardiac Ablation Solutions business president Rebecca Seidel said: “Treating the final patient in the fast-moving SPHERE Per-AF Trial builds on the exciting phase of innovation and growth at Medtronic over the last year, including the acquisition of Affera, our agreement to distribute a differentiated portfolio of left-heart access tools and devices to support a zero-exchange procedure workflow, and the continued progress in the development of PulseSelect, our organic pulsed field ablation (PFA) system.”
The Sphere-9 cardiac ablation and mapping catheter provides intuitive HD mapping for diagnosing arrhythmias and treating patients using a single catheter.
It combines mapping, navigation and therapeutic capabilities as well as delivery of RF and PF energies in one catheter for ablation purposes.
It gives physicians the ability to customise treatment during an ablation procedure based on the requirements of the patient.
Last month, Medtronic reported a 3% decline in its global revenue for the second quarter (Q2) of the fiscal year 2023.