Sphere-9™ catheter
for cardiac mapping and ablation
The first-of-its-kind, all-in-one Sphere-9™ catheter provides high density (HD) mapping and dual-energy ablation including radiofrequency (RF) and pulsed field (PF) energies.
Overview
All-in-one: map | ablate | validate
The novel, Sphere-9™ catheter is an all-in-one tool enabling physicians to map, ablate, and validate with a single transeptal, zero-exchange workflow.
The compressible lattice tip with wide-area focal design and close unipolar mapping capability offers proven safety, efficacy, and superior efficiency1 to promote confidence in procedural outcomes.
Sphere-9™ catheter at a glance
- 9 mm, compressible lattice ablation electrode
- 9 mini electrodes with integrated thermocouples
- Central reference electrode
- Low flow, central irrigation
- 8 Fr, bi-directional shaft
Features
Map
Create high density maps in less than 11 minutes with greater than 5000 points.2
Close-unipolar mapping provides the benefits of bipolar and unipolar electrograms3 while avoiding the challenges of each.
- Maintain wavefront morphology
- Reduce far-field potentials
- Provide high fidelity and discreate EGMs
Ablate
Experience superior efficiency1 with a wide-area focal tip and dual energy ablation capabilities; RF and PF.
Wide-area focal lattice ablation electrode
- 10x larger effective surface area4
- Compressible tip for conformability and stability4,5
- THERMOCOOL SMARTTOUCH™* SF
- Sphere-9™
RF and PF ablation options
- 4–5 seconds energy application time
- PF Lesions: > 17 mm wide6
- RF Lesions: > 19 mm wide7
Validate
Conveniently remap or effortlessly proceed from ablation to validation without switching catheters.
An integrated stimulator supports exclusive pace modes specifically designed for the Sphere-9™ catheter.
Quickly confirm block using the propagation arrow and additional pacing features.
Trials
SPHERE Per-AF randomized IDE clinical trial1
The SPHERE Per-AF trial compared the Sphere-9™ catheter with Affera™ mapping and ablation system to the THERMOCOOL SMARTTOUCH™* SF catheter with CARTO mapping system for the treatment of Persistent AF.
- 1.4% primary safety events vs. 1% when using STSF
- 74% primary effectiveness rate
- 80% effectiveness ≥ 10 cases8
- 25+ minutes saved per procedure
Resources
Related links
Education resources on Medtronic Academy
Access detailed product information, including spec sheets, videos, and presentations.
™* Third-party brands are trademarks of their respective owners.
1. Anter E, Mansour M, Nair DG, et al. Dual-energy lattice-tip ablation system for persistent atrial fibrillation: a randomized trial. Nat Med. 2024;30(8):2303–2310. doi: 10.1038/s41591-024-03022-6.
2. Reddy VY, Anter E, Rackauskas G, et al. Lattice-tip focal ablation catheter that toggles between radiofrequency and pulsed field energy to treat atrial fibrillation: a first-in-human trial. Cir Arrhythm Electrophysiol. 2020;13(6):e008718. doi: 10.1161/CIRCEP.120.008718.
3. De Bakker JMT. Electrogram recording and analyzing techniques to optimize selection of target sites for ablation of cardiac arrhythmias. Pacing Clin Electrophysiol. 2019;42(12):1503–1516. doi: 10.1111/pace.13817.
4. Anter E, Neužil P, Rackauskas G, et al. A lattice-tip temperature-controlled radiofrequency ablation catheter for wide thermal lesions: first-in-human experience with atrial fibrillation. JACC Clin Electrophysiol. 2020;6(5):507–519. doi: 10.1016/j.jacep.2019.12.015.
5. Shapira-Daniels A, Barkagan M, Yavin H, et al. Novel irrigated temperature-controlled lattice ablation catheter for ventricular ablation: a preclinical multimodality biophysical characterization. Circ Arrhythm Electrophysiol. 2019;12(11):e007661. doi: 10.1161/CIRCEP.119.007661.
6. Yavin HD, Higuchi K, Sroubek J, Younis A, Zilberman I, Anter E. Pulsed-field ablation in ventricular myocardium using a focal catheter: The impact of application repetition on lesion dimensions. Circ Arrhythm Electrophysiol. 2021;(9):e010375. doi: 10.1161/CIRCEP.121.010375.
7. Barkagan M, Leshem E, Rottmann M, Sroubek J, Shapira-Daniels A, Anter E. Expandable lattice electrode ablation catheter: a novel radiofrequency platform allowing high current at low density for rapid, titratable, and durable lesions. Circ Arrhythm Electrophysiol. 2019;12(4):e007090. doi: 10.1161/CIRCEP.118.007090.
8. Kiehl E, et al. Operator learning curve with a novel dual-energy lattice-tip ablation system. Presented at Asia-Pacific Heart Rhythm Society; September 28, 2024; Sydney, Australia.
DISCLAIMER
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