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 WarningsIndicationsThe Sphere-9™ catheter is indicated for use in cardiac electrophysiological mapping (stimulation and electrogram recording) and for treatment of drug refractory, recurrent, symptomatic persistent atrial fibrillation (episode duration less than 1 year) and radiofrequency ablation of cavotricuspid isthmus dependent atrial flutter when used with the Affera™ mapping system.The Affera™ integrated mapping system is intended to be used for catheter-based cardiac electrophysiological mapping. The mapping system allows pacing and real-time visualization of compatible catheters as well as display of cardiac maps in multiple formats. The acquired patient signals, including body surface electrocardiograms and intracardiac electrograms, may also be recorded and displayed on the system’s display screen.ContraindicationsDo not use this device under the following circumstances:

In patients with an active systemic infection.

In patients who have had cardiac surgery in the preceding eight weeks, as the risk of perforation may increase.

In patients with intracardiac thrombus or myxoma, as the catheter may precipitate an embolus.

In coronary vessels with diameter smaller than the expandable ablation electrode, as the catheter may damage the coronary vessels.

In patients with prosthetic valves, as the catheter may damage the prosthesis.

Using the transaortic valve retrograde approach in patients who have had aortic valve replacement.

Using the transseptal approach in patients with an interatrial baffle or patch, as the opening could persist and result in an iatrogenic atrial shunt.

Warnings and Precautions
Do not reuse, reprocess, or resterilize devices labeled single-use only. Only use with compatible devices listed in the instructions for use. The Affera integrated mapping system requires use of a set of proprietary localization patches to detect patient displacement and respiratory motion and deliver low energy patient auxiliary signals.Treatment location should be confirmed using alternative techniques (e.g. fluoroscopy, intracardiac electrograms, intracardiac echocardiography) before treatment. A connection to a compatible cardiac stimulator is allowed provided the stimulator is electrically isolated or physically disconnected when RF or PF energy is applied to the patient, outputs of the generator and stimulator must be isolated to prevent patient injury or damage to equipment.The pacing functionality in the Affera integrated mapping system is not a life support device and is for diagnostic purposes only. Pacing may induce intentional or unintentional life-threatening cardiac arrhythmias.Intravenous heparin must be used to reduce the likelihood of thromboemboli developing during the procedure. Patient injury may result from excessive delivery of fluids. Anticoagulation treatment should adhere to consensus guidelines,Avoid steering the Sphere-9 catheter near other catheters to reduce the possibility of the catheters becoming entangled. Cardiac devices may be damaged by energy delivery. Catheter interactions with implantable leads may result in lead dislodgement or possible thrombus.Cardiac ablation may induce intentional or unintentional life-threatening cardiac arrhythmias. RF therapy with the Sphere-9 catheter in patients who have a Biotronik™ ICD/CRT-D device may result in induction of ventricular tachycardia / ventricular fibrillation. Care should be taken when ablating near sensitive structures (i.e., conduction system, coronary arteries) as unintended patient harm may occur. Catheter entrapment within the heart is a possible complication of cardiac ablation procedures that could necessitate surgical intervention.The Affera integrated mapping and ablation system has not been evaluated for safety and compatibility in the magnetic resonance (MR) environment. System operation may be temporarily interrupted if exposed to excessive external electromagnetic disturbance or electrostatic discharge.Potential Adverse Events or Potential Complications
Arrhythmia, Atrioesophageal fistula, Cardiac perforation / tamponade, Cardiac or respiratory arrest, Conduction system injury, Coronary artery spasm / occlusion / stenosis, Damage / dislodgement to implantable leads, Damage / dysfunction of cardiac devices, Death, Embolism, Hemoptysis, Infection, Myocardial infarction, Phrenic nerve palsy / paralysis, Pulmonary edema, Pulmonary vein stenosis, Stroke, Valve damage, Vessel dissectionRefer to the device technical manual for detailed information regarding the procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1-800-328-2518 and/or consult the Medtronic website at www.medtronic.com.Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.US-SE-2500347 v3.0

Sphere-9^™ mapping and ablation catheter features

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 access, 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: A high-density mapping catheter to support your ablation strategies

Create high-density maps in less than 11 minutes with greater than 5,000 points.²

Unique, 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 discrete EGMs.

Ablate: Dual-energy pulsed field and radiofrequency ablation

Experience superior efficiency¹ with a wide-area focal tip and dual-energy ablation capabilities.

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 than 18 mm wide⁷

Validate: Confirm ablation

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.

Clinical and economic evidence for the Sphere-9™ mapping and ablation catheter

SPHERE Per-AF IDE trial¹

The SPHERE Per-AF trial was a randomized trial evaluating the safety, effectiveness, and efficiency of the Sphere-9™ catheter with the Affera™ mapping and ablation system for the treatment of patients with persistent atrial fibrillation.

View SPHERE Per-AF data

Lab efficiency and health economics of the Sphere-9™ catheter^8,9

Analyses based on the SPHERE Per-AF trial demonstrate how the Sphere-9™ catheter enables predictable procedure time,^†,8 allows for reduced overtime,^†,8 and supports same-day discharge.⁹

Understand the data

† Based on a discrete event simulation of 1,000 lab days using the SPHERE Per-AF trial data. These are not endpoints from the SPHERE Per-AF study but rather hypothetical modeling based on the data generated from the SPHERE Per-AF study.

Ordering information

Item number	Description
AFR-00001	Sphere-9™ mapping and ablation catheter

Resources

View the Sphere-9™ catheter features and benefits.

Sphere-9™ Catheter Features and Benefits (open in new window)

View this one pager to learn the key product features of the Sphere-9™ catheter as well as the high level Sphere Per-AF clinical trial data.

PRODUCT PDF 733 KB

View the SPHERE Per-AF clinical summary brochure.

SPHERE Per-AF Clinical Summary Brochure (open in new window)

View this brochure to learn about the pertinent safety, efficacy and efficiency data from the SPHERE Per-AF clinical IDE trial.

CLINICAL EVIDENCE PDF 1 MB

View this document describing the specifications of the Sphere-9™ mapping and ablation catheter.

Sphere-9™ Catheter Spec Sheet (open in new window)

Download this spec sheet to learn about the Sphere-9™ catheter product specifications.

PRODUCT PDF 629 KB

This is a document describing specifications of the Affera™ cardiac mapping system.

Affera™ Prism-2 Capital System Spec Sheet (open in new window)

This is the brochure of specifications of the Affera™ mapping and ablation system.

PRODUCT PDF 941 KB

View the Affera™ mapping and ablation system brochure.

Affera™ Mapping and Ablation System Brochure (open in new window)

Download this multipage brochure, which provides a multipage overview of the main features and benefits of the Affera™ mapping system and Sphere-9™ catheter.

PRODUCT PDF 1 MB

A 25-page clinical evidence featuring key studies and publications for the all-in-one, dual-energy Sphere-9™ catheter.

Sphere-9™ Catheter Clinical Compendium (open in new window)

View this report for clinical evidence featuring key studies and publications for the all-in-one, dual-energy Sphere-9™ catheter.

PRODUCT PDF 638 KB

TM* Third-party brands are trademarks of their respective owners.

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.
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. Circ Arrhythm Electrophysiol. 2020;13(6):e008718. doi:10.1161/CIRCEP.120.008718.
de Bakker JM. 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.
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.
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.
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;14(9):e010375. doi:10.1161/CIRCEP.121.010375.
REF-32517. S6585 GLP study. June 2023. Medtronic data on file.
Mountantonakis SE, Anter E, Marschke J, et al. Electrophysiology lab efficiency simulation: a comparison between novel dual-energy lattice-tip and conventional contact-force sensing radiofrequency ablation systems. J Invasive Cardiol. 2025;37(12):10.25270/jic/25.00094. doi:10.25270/jic/25.00094.
Taigen TL, Nair DG, Sharma D, et al. Same day discharge can be performed safely after atrial fibrillation catheter ablation using a wide-footprint lattice-tip dual-energy system. Heart Rhythm O2. 2026;7(4):656–663. doi:10.1016/j.hroo.2026.01.015.

Sphere-9™ catheter

Sphere-9^™ mapping and ablation catheter features

Sphere-9™ mapping and ablation catheter at a glance

Map: A high-density mapping catheter to support your ablation strategies