| Item number | Description |
|---|---|
| AFR-00012 | Sphere-360™ PFA catheter |
PF ablation catheters
<p>Sphere-360™ pulsed field ablation (PFA) single shot catheter delivers mapping and rotation free ablation for paroxysmal atrial fibrillation treatment.</p>
Designed for every EP, the Sphere‑360™ PFA system delivers safe, efficient, and durable PVI through a simple ZeroTurn™ workflow1. It achieves complete isolation in only four applications with no catheter rotation needed.
The adjustable lattice seamlessly expands from linear to disc shape up to 34 mm, adapting to a wide range of PV anatomies.1
Deliver circumferential Span360™ ablation lesions2 with zero rotation.
The catheter provides easy maneuverability with a conformable,3 atraumatic lattice.
The Sphere‑360™ PFA catheter is exclusively integrated with the Affera™ mapping and ablation system. Its all‑in‑one design delivers navigation, mapping, and ablation through a single catheter.
Get access to refined insights with Prism-2 mapping software and real-time tissue proximity feedback.
Real-time local impedance
Lesion tags and location
Low- to zero-fluoro
Visualize coronary sinus catheter
The Sphere-360™ mapping and ablation catheter is compatible with the zero exchange and single transseptal puncture workflows. These workflows are enabled by the FlexCath Contour™ steerable sheath and FlexCath Cross™ transeptal solution.
The Sphere-360™ catheter delivers predictable workflows and lasting results across centers — with reliability and confidence in your procedure.
The Sphere-360™ CE Mark study was a prospective, single-arm, multicenter trial. It was designed to evaluate the safety, effectiveness, and lesion durability of the Sphere-360™ catheter. The catheter was used for the treatment of symptomatic, drug-refractory paroxysmal atrial fibrillation (PAF) in 100 patients.¹
Sphere-360™ offers a new generation catheter for a single shot ablation. The high conformability of the catheter performs very well. Because it is a compliant sphere, it can adapt to the tissue ... It can be seamlessly adapted to different shapes, because the anatomy of the pulmonary vein is highly individualized.”
– Petr Peichl, MD, PhD, on his experience with the Sphere-360™ PFA catheter for AF treatment
| Item number | Description |
|---|---|
| AFR-00012 | Sphere-360™ PFA catheter |
† Fifty patients treated with the PULSE3 optimized and most recent waveform configuration, 40 of which completed the optional remapping procedure.
‡ See manuscript for all adverse event incidence.
§ Total cohort (N = 100).
◊ Four patients done with 0 fluoro; 26 patients with less than or equal to three minutes of fluoro.
You just clicked a link to go to another website. If you continue, you may go to a site run by someone else.
We do not review or control the content on non-Medtronic sites, and we are not responsible for any business dealings or transactions you have there. Your use of the other site is subject to the terms of use and privacy statement on that site.
It is possible that some of the products on the other site are not approved in your region or country.