The Affera mapping and ablation system includes Sphere-9 Catheter with pulsed-field ablation, radiofrequency, and high-density mapping, integrated with an intuitive mapping and navigation platform
Medtronic has secured a CE mark for its Affera Mapping and Ablation System, comprising Sphere-9 Catheter and Affera Prism-1 Mapping Software, to treat atrial arrhythmias.
Affera system is designed to map and ablate atrial arrhythmias and provide real-time feedback through its intuitive mapping and navigation software.
Its Sphere-9 catheter facilitates pulsed field ablation catheter (PFA), radiofrequency (RF), and high-density (HD) mapping.
The catheter, together with an integrated mapping and navigation system, will rapidly generate complex electro-anatomical maps.
The mapping allows the physician to deliver wide-area focal ablation lesions of choice between RF and PFA, based on the patient and procedure needs.
Sphere-9 catheter’s nitinol 9mm ablation tip requires fewer focal ablation lesion applications, which reduces procedure times compared to standard irrigated ablation catheters.
The mapping software delivers an optimised user experience through streamlined insights and feedback, said the medical device maker.
Medtronic Cardiac Ablation Solutions business vice president and chief medical officer Khaldoun Tarakji said: “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.
“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.”
The CE mark is supported by results from clinical studies assessing the safety and performance of the Sphere-9 Catheter and Mapping System.
In December last year, the company completed enrolment in the US Food and Drug Administration (FDA) Investigational Device Exemption (IDE) trial, Affera SPHERE Per-AF.
The clinical trial is designed to evaluate the safety and effectiveness of the Affera Mapping and Ablation System for the treatment of persistent atrial fibrillation.
Medtronic intends to commercialise Affera Mapping and Ablation System in Europe, starting from the first half of 2023.
Medtronic Cardiac Ablation Solutions president Rebecca Seidel said: “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.
“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.”