PF ablation catheters

Sphere-9™ catheter

<p>The Sphere-9™ mapping and ablation catheter provides mapping and dual-energy ablation options including radiofrequency (RF) and pulsed field (PF) energies.</p>

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Indications, Safety, and WarningsAffera™ integrated mapping and ablation systemIndicationsThe 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 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 IFU. The Integrated Affera 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.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 ESD.Potential adverse events or potential complications
Atrioesophageal fistula, Cardiac perforation / tamponade, Cardiac or respiratory arrest, Stroke Conduction system injury, Coronary artery spasm / occlusion / stenosis, Damage / dislodgement to ICD or implantable pacemaker, Death, Embolism, Hemoptysis, Infection, Myocardial infarction, Phrenic nerve palsy / paralysis, Pulmonary edema, Pulmonary vein stenosis, 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 v1.0

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, 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 five callouts.

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

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

THERMOCOOL SMARTTOUCH™* SF
Sphere-9™ catheter

This is an image comparing the size of the THERMOCOOL SMARTTOUCH™* and Sphere-9™ catheters.

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

Ordering information

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

Resources

This is a brochure describing the key product features of the Sphere-9™ pulsed field ablation catheter as well as the high level Sphere Per-AF clinical trial data.

Sphere-9™ Catheter Brochure (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 1 MB

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

This brochure describes the results from the Sphere Per-AF clinical trial with the Sphere-9™ PF ablation catheter on the Affera™ mapping and ablation system.

CLINICAL EVIDENCE PDF 1 MB