Enrollment Completed in Pivotal Medtronic Ablation Catheter Trial
Medical device company Medtronic recently announced that enrolment and final treatment had been completed in the SHPERE Per-AF Trial, a US FDA (Food and Drug Administration) IDE (Investigational Device Exemption) trial which was designed for safety and effectiveness evaluation of the Sphere-9 first-of-its-kind catheter for pulsed field, radiofrequency ablation and high-density mapping, with the Affera mapping and cardiac navigation platform used for treating persisting AF (atrial fibrillation). The Affera platform, which is designed to improve efficiency, enables intuitive high definition mapping, in order to diagnose arrhythmias while treating patients with just one catheter. The Sphere-9 combines therapeutic, navigation and mapping capabilities, and is the only existing catheter which can deliver both RF energies and PF energies for ablation. This provides physicians with an ability to customize treatment around a patient’s needs throughout an ablation procedure. "During the trial, my observations and experience with the novel Affera system have been very promising," said Devi Nair, M.D., FHRS, Director of Cardiac Electrophysiology & Research, St. Bernards Medical Center, Jonesboro, Arkansas, a participating site in the SPHERE Per-AF trial. "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 SPHERE Per-AF Trial is a multicenter, global and prospective randomised clinical trial. Since it began in December 2021, it has enrolled 477 patients suffering with persistent AF, spanning 23 centres in Europe and the US. Patients will undergo assessment over 12 months to ensure safety and efficacy. "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 PFA system," said Rebecca Seidel, president, Cardiac Ablation Solutions business, which is part of the Cardiovascular Portfolio at Medtronic. "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 commercialize a full, comprehensive portfolio to help physicians treat patients around the world." Acquired by Medtronic in August 2022, the Affera product portfolio is not, at present, currently approved or available for either sale or commercial use.