Affera includes the Sphere-9 catheter and the Affera Prism-1 mapping software. The company initially won CE mark for the system about two years ago and plans to bring it to more Nordic countries after Sweden “soon.”
The medtech giant received FDA approval for its Affera mapping and ablation system with the Sphere-9 catheter in October 2024. Approval made the company the first and only company with two PFA technologies available for treating AFib. The medtech giant also makes the PulseSelect PFA system, which last year became the first PFA system to win FDA approval. Medtronic also last year received the FDA’s green light to study the system in treating ventricular tachycardia (VT).
Affera maps and ablates atrial arrhythmias, such as AFib. It provides real-time feedback through intuitive mapping and navigation software. The system utilizes the Sphere-9 catheter to offer physicians the option of both PF and RF energy delivery. With the mapping and ablation combination, Medtronic says it enhances workflow efficiency for physicians while providing excellent safety and efficacy outcomes.
In a news release, the company said: “Medtronic is currently the only medtech company able to provide this unique system, reinforcing its commitment to delivering groundbreaking solutions for cardiac arrhythmia treatment. The Affera mapping and ablation system will soon be introduced in additional Nordic countries, expanding access to this innovative technology.”
Medical Design & Outsourcing: Medtronic’s Affera Sphere-9 dual-energy ablation and mapping catheter uses nitinol in a new way
