PF ablation catheters

Sphere-9™ catheter

<p>The Sphere-9™ catheter provides HD mapping and dual-energy pulsed field (PF) and radiofrequency (RF) ablation in one zero exchange platform.</p>

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Indications, Safety, and WarningsThe material on this website should not be considered the exclusive source of information, it does not replace or supersede information contained in the device manual(s).Please note that the intended use of a product may vary depending on geographical approvals.See the device manual(s) for detailed information regarding the intended use, the implant procedure, indications, contraindications, warnings, precautions, and potential adverse events.For a MRI compatible device(s), consult the MRI information in the device manual(s) before performing a MRI.If a device is eligible for eIFU usage, instructions for use can be found at the Medtronic website manuals.medtronic.com.Manuals can be viewed using a current version of any major internet browser. For best results, use Adobe Acrobat® Reader with the browser.Medtronic products placed on European markets comply with EU and UK legislation (if applicable) on medical devices. For any further information, contact your local Medtronic representative.Medtronic medical devices marketed in Spain are in compliance with the Spanish legislation in force.

Features

All-in-one: map | ablate | validate

The 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.

This is an image of the Sphere-9™ catheter with numbered callouts.

Sphere-9™ mapping and ablation catheter at a glance

9 mm proprietary nitinol lattice for compressibility and stability
9 mini electrodes for unique, Close-Unipolar™ mapping
9 integrated thermocouples for real-time temperature sensing during ablation
8 Fr bidirectional shaft with 1:1 torque response

Download catheter spec sheet (open in new window)

Map

Create high-density maps in less than 11 minutes with greater than 5,000 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

10 times larger effective surface area⁴
Compressible tip for conformability and stability^4,5

This is an image comparing the size of the Sphere-9™ PF and RF ablation catheter with the THERMOCOOL SMARTTOUCH™* SF catheter.

Sphere-9™ catheter
THERMOCOOL SMARTTOUCH™* SF catheter

RF and PF ablation options

4–5 second energy application time
PF lesions greater than 17 mm wide⁶
RF lesions greater than19 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.

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.

View SPHERE Per-AF data

Ventricular tachycardia (VT) ablation with the Sphere-9 catheter

Revolutionizing treatment for a significant unmet need in electrophysiology, understand the data supporting the use of the all-in-one Sphere-9 catheter in patients with VT and premature ventricular contractions (PVCs).

View the data