Mapping and ablation products

Affera™ mapping and ablation system

<p>The Affera™ mapping and ablation system empowers physicians to accurately map and safely ablate with all-in-one HD mapping and dual-energy functionality.</p>

Ordering information

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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

Automate

Automatic and continuous collection

Collect everything; display the rhythm you want to see.

Fast remap and cloning

Start a new map quickly and efficiently while maintaining the active map‘s geometry, chamber, rhythm, window of interest, or even EGM data.

Left: AT at 400 ms Right: AT at 300 ms

Inform

Explore multiple standout tools from Affera™ cardiac mapping system designed to simplify intraprocedural complexity.

Automatic tags

Tag shape and colors provide instant insights about tip location, orientation, and lesion creation.

AfferaConnect™ line

Visually confirm ablation groups and lesion set contiguity.

Sensor globe and temperature globe

Real-time mapping and ablation guide

Local impedance feedback

Local impedance indicators define catheter tip to tissue proximity.

Optimize

Vein mode

Designed to delineate complex regions of the heart, which may reduce the use of fluoroscopy^1,2

Propagation arrow

Assess wavefront directionality
for every beat before, during, and after ablation to enhance clinical decision-making.

Integrated stimulator

Expedite differential pacing workflows for assessing therapeutic outcomes.

Specifications

This is an image of the Affera™ Capital system.

Capital components

HexaFlow™ irrigation pump
Compatible with single-use tubing set and integrated IV pole on system cart
HexaGen™ RF generator
Temperature-controlled RF for the creation of wide-area focal lesions
HexaPulse™ PF generator
Unipolar, biphasic PF energy delivery
HexaMap™ catheter interface unit (CIU)
Synergy navigation for map acquisition with compatible catheter displays and records intracardiac electrograms while providing pacing.

Ordering information

The components below are typically ordered together to create a functioning system.

Affera™ mapping and navigation system

Item number	Product name	Details	Package
AFR-00016	Affera™ mapping system	Includes Prism-2 mapping software, magnetic field generator, HexaMap™ CIU, workstation, cables, accessories	Bundle
AFR-00008	HexaPulse™ PF generator	Includes PFG assembly, cables/accessories
AFR-00004	HexaGen™ RF generator	Includes RFG assembly, remote control, foot pedal, cables/accessories
AFR-00005	HexaFlow™ irrigation pump	Includes pump, pole mount, cables/accessories
AFR-00013	System cart	Customized for Affera™ system components

Disposables

Item number	Product name	Details	Package
AFR-00001	Sphere-9™ catheter	Combined mapping and ablation catheter	1 each
AFR-00002	Tubing set	Compatible with HexaFlow™ irrigation pump	4 pack
AFR-00006	Catheter extension cable	Single-use cable for use with Sphere-9™ catheter and Affera™ system	1 each
AFR-00015	Impedance localization patch kits	Single-use patches for catheter visualization	6 patches per kit, 4 kits per order

Resources

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

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

Download this one-pager to read about system specifications for the Affera™ mapping system.

PRODUCT PDF 498 KB

This is a multipage brochure which describes features and benefits of the Affera™ cardiac mapping system and the Sphere-9™ ablation catheter.

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

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

PRODUCT PDF 1 MB

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

Affera™ Mapping System Features and Benefits (open in new window)

Download this one pager, which outlines the features and benefits of the Affera™ mapping system.

PRODUCT PDF 691 KB

This is a brochure describing the safety, efficacy, and efficiency data from the Sphere Per-AF clinical IDE trial with the Sphere-9™ pulsed field ablation catheter.

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

Download 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

This is a document describing the specifications of the Sphere-9™ mapping and ablation catheter.

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

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

PRODUCT PDF 491 KB

Educational resources on Medtronic Academy

Access detailed product information, including spec sheets, videos, and presentations.

Visit Medtronic Academy (open in new window)

Anter E, Mansour M, Nair DG, et al. Dual-energy lattice-tip ablation system for persistent atrial fibrillation: a randomized trial. Nat Med. August 2024;30(8)2303–2310.
Affera™ mapping system software manual, M050220C001 (Agile). 2024.

Affera™ mapping and ablation system