Mapping and ablation products

Affera™ mapping and ablation system

<p>The Affera™ mapping and ablation system is an all-in-one solution that enables simple, effective, and reproducible procedures.</p>

Ordering information

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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 Medtronic’s 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 of the Affera™ mapping and ablation system

Intuitive mapping solution

Effective, high-fidelity mapping

Quickly generate high-fidelity, realistic anatomy to enable identification of ablation targets.

Synergy navigation

Utilize hybrid impedance and magnetic mapping modalities for visualization of non-sensor-based catheters.

Beat Matching

Filter maps to electrogram data matching the ECG morphology of a beat of interest.

Automatic and continuous data collection

Display any point regardless of the map filters used during collection.

Left: Activation map. Right: Voltage map.

Refined electrophysiology mapping insights

Explore several of the smart, optimized clinical tools from the Affera™ mapping system.

Automatic, intelligent tags

Leverage instant analysis from Pace Tags about paced morphology response, and Lesion Tags about lesion location, orientation, and quality.

AfferaConnect™ line

Visually confirm ablation groups and lesion set contiguity.

Sensor globe and temperature globe

Consult the real-time mapping and ablation guide for local impedance feedback and tissue temperature display during radiofrequency (RF) and pulsed field (PF) delivery.

AfferaTouch™ feature

Refer to the real-time local impedance indicator providing tissue proximity feedback.

Propagation arrow

Assess wavefront directionality for every beat before, during, and after ablation.

This is an image of the Pace Tagging feature on the Affera™ mapping and ablation system.

Pace Tags

Leverage instant insights from Pace Tag scores and colors about paced morphology via Pace Tagging analysis.

Streamlined electrophysiology workflows

Integrated stimulator

Expedite pacing workflows with custom pacing modes and Pace Tagging pacing analysis.

Low- to zero-fluoro cardiac mapping workflows

Further or entirely reduce fluoroscopy time with synergy navigation.

Seamless dual-energy modality transition

Easily and quickly transition between energy sources to deliver safe,¹ durable² lesions for ablation.

Simple EP lab setup

Simplify lab and ablation procedure preparation with direct 12-lead signal acquisition.

Affera™ mapping and ablation system specifications

This is an image of the Affera™ capital system.

Capital components

HexaFlow™ irrigation pump
Responsive, automated irrigation and bubble detection
HexaGen™ RF generator
Temperature-controlled RF energy delivery
HexaPulse™ PF generator
Unipolar, biphasic PF energy delivery
HexaMap™ catheter interface unit (CIU)
Magnetic impedance navigation and map acquisition with intracardiac electrogram and electrocardiogram display, recording, and 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