Medtronic (NYSE:MDT) announced today that it received CE mark approval for its Affera mapping and ablation system.
The Affera system includes the Sphere-9 catheter and Affera Prism-1 mapping software. Together, the system integrates Sphere-9 pulsed-field ablation (PFA), radiofrequency (RF) and high-density (HD) mapping. It maps and ablates atrial arrhythmias — including AFib — and provides real-time feedback through its mapping and navigation software.
Sphere-9 combines with the mapping and navigation system to generate sophisticated electro-anatomical maps. These allow the physician to deliver wide-area focal ablation lesions of choice between RF or PFA. The catheter features a nitinol 9mm ablation tip that may allow for fewer focal ablation lesion applications. Medtronic said it could result in lower procedure times compared to standard irrigated ablation catheters. The company added that the mapping software enables an optimized user experience with streamlined insights and feedback.
Medtronic brought in these technologies through its $1 billion acquisition of Affera in August 2022. The ablation space remains hot, with Medtronic, Boston Scientific and Johnson & Johnson MedTech’s Biosense Webster all developing ablation tech. Those companies recently shared positive study data for their respective ablation systems at ACC.23.
The Medtronic Affera ablation system represents “a great advancement”
Dr. Khaldoun Tarakji, VP and CMO of Medtronic’s Cardiac Ablation Solutions Business, said that current technologies require the use of separate HD mapping and ablation catheters. The option to map, ablate and validate with the Sphere-9 catheter eliminates the need to exchange catheters and pick energy sources based on patient needs.
“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,” said Tarakji. “All this leads to improving efficiency and most importantly, enhancing the safety of ablation procedures for our patients.”
Results from clinical studies assessing safety and performance of the Affera system supported CE mark, Medtronic said. The company announced in December that it completed enrollment in its FDA investigational device exemption trial for the system. It remains investigational in the U.S. Medtronic plans to commercially launch the Affera system in Europe in the first half of this year.
“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 of the Cardiac Ablation Solutions business at Medtronic. “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.”
PulseSelect, which recently exceeded the safety goal in a clinical trial, remains investigational worldwide.