Medtronic’s Affera Mapping and Ablation System Gains EU Nod

Medtronic has received CE mark clearance for its Affera mapping and ablation system, which includes the Sphere-9 catheter and Affera Prism-1 mapping software.
 
Together, the system creates a new electrophysiology paradigm using the Sphere-9 pulsed field ablation (PFA), radiofrequency (RF), and high-density mapping catheter. Sphere-9 maps and ablates atrial arrhythmias and generates real-time feedback via mapping and navigation software.
 
Coupled with the integrated mapping and navigation, Sphere-9 and the full system creates sophisticated electro-anatomical maps so the physician can deliver wide-area focal ablation lesions of choice between RF or PFA based on patient and procedure needs. The catheter’s  nitinol 9 mm ablation tip has the potential to need fewer focal ablation lesion applications, which may cause lower procedure times.
 
“The revolutionary Affera Mapping and Ablation System combined with the novel Sphere-9 Catheter represent a great advancement in the field of HD mapping and focal ablation,” Khaldoun Tarakji, M.D., MPH, VP and chief medical officer of Medtronic’s Cardiac Ablation Solutions business told the press. “Current technologies require the use of separate HD mapping and ablation catheters. The ability to map, ablate, and validate with the Sphere-9 Catheter enables the physician to eliminate the need to exchange catheters and empowers them to choose the energy source, whether RF or PF, based on the patient’s needs. All this leads to improving efficiency and most importantly, enhancing the safety of ablation procedures for our patients.”
 
CE mark approval follows a December 2022 announcement that enrollment was completed in the Affera SPHERE Per-AF clinical trial, an FDA IDE pivotal trial to evaluate Affera to treat persistent atrial fibrillation. The trial is currently in its 12-month follow-up phase.
 
“Electrophysiology is evolving at a rapid pace, and we believe we are uniquely positioned to be category creators once again with the all-in-one Sphere-9 Catheter, just as we did when Medtronic pioneered cryoablation technology,” said Rebecca Seidel, president, Cardiac Ablation Solutions. “Along with the PulseSelect PFA System, we are proud to be among the first to bring novel single shot and focal PF technologies to patients around the world.”
 
Affera will be available in the first half on 2023 in Europe and is investigational in the U.S. Medtronic acquired Affera in August 2022.