SPHERE Per-AF is the US Food and Drug Administration (FDA) Investigational Device Exemption (IDE) trial of the ablation catheter that enrolled 477 patients with persistent AF across 23 centres in the US and Europe
Medtronic Sphere-9 mapping, navigation, and ablation catheter. (Credit: Medtronic)
Medtronic has completed the patient recruitment and final treatment in the SPHERE Per-AF trial of its Sphere-9 pulsed field (PF), radiofrequency (RF) ablation mapping catheter.
SPHERE Per-AF is the US Food and Drug Administration (FDA) Investigational Device Exemption (IDE) trial of the company’s ablation catheter for atrial fibrillation (AF).
Commenced in December last year, the clinical trial recruited 477 patients with persistent AF across 23 centres in the US and Europe, who will be assessed for 12 months.
It is designed to evaluate the safety and effectiveness of the catheter, used with the Affera cardiac mapping and navigation platform, in treating persistent AF.
St. Bernards Medical Centre cardiac electrophysiology and research director Devi Nair said: “During the trial, my observations and experience with the novel Affera system have been very promising.
“Unlike conventional technologies, I’ve been impressed with the ability to both map and ablate with the option of dual energy sources, with one catheter.
“I look forward to the results of the trial and remain optimistically enthusiastic as I continue to understand the safety and efficacy of the Sphere 9 ablation catheter.”
The investigational technology includes the Affera mapping and navigation platform, which enables intuitive HD mapping to diagnose arrhythmias and treat patients with one catheter.
In August this year, Medtronic acquired Affera, whose product portfolio is currently not approved or available for sale or for commercial use.
Together with Affera platform, the Sphere-9 catheter combines mapping, navigation, and therapeutic capabilities.
It is the only catheter to deliver both RF and PF energies and allows physicians to customise treatment during an ablation procedure, said the company.
Medtronic 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.
“Thanks to the innovation and expertise within Affera and the support of our Medtronic team, together we’re able to continue to evaluate new, best-in-class solutions and commercialise a full, comprehensive portfolio to help physicians treat patients around the world.”