Affera™ Mapping and Ablation System
Experience a new paradigm in electrophysiology
Meet the Affera™ Mapping and Ablation System
The Affera™ Mapping and Ablation System creates a new paradigm in EP through the unique integration of the:
- All-in-one Sphere-9™ Catheter to create high density (HD) maps, ablate with either pulsed field (PF) or radiofrequency (RF) energy, and validate.
- Affera™ Prism-1 Mapping Software elevates the norm and removes complexity.
Sphere-9™ Catheter
All-in-one map | ablate | validate
See for yourself as this one-of-a-kind catheter completes every step of an ablation procedure.
For electrophysiologists who are seeking faster, more predictable and flexible procedures, the Sphere-9™ Catheter comes with innovative functionalities for the treatment of cardiac arrhythmias, including both RF and PF options in one catheter.
Unparalleled versatility
- HD mapping leveraging close unipolar EGMs1
- One, single catheter with dual energy2 capabilities, RF and PF
Absolute control
- Tissue contact and stability through innovative 9 mm, conformable lattice tip
- 9 mini electrodes providing accurate, real-time tissue temperature monitoring1
Optimized workflow
- Safe1,2 and effective1,2 procedures in less time,2 using fewer wide-area focal lesions 1,3
- Single transseptal access and zero exchanges for optimized workflow
Sphere-9™ catheter at a glance
- Nitinol lattice ablation electrode
- Nine Platinum-iridium electrodes
- Central reference electrode
- Central irrigation
- 8Fr Bi-directional steerability (D-F)
- Handle controller for mapping management
- Magnetic location sensors for curve visualization
Affera™ Prism-1 Mapping Software
Elevating the norm
Built with user experience in mind, the Affera™ Prism-1 Mapping Software addresses the most common needs of today’s electrophysiologists with elegant features and an innovative suite of software functionalities to enhance clinical workflows, now and in the future.
Intuitive interface
A modern, sleek interface designed to enhance and streamline the interpretation of complex information
Integrated platform
Purposefully built for an optimized Sphere-9™ user experience and forthcoming developments and catheter technologies
Insightful algorithms
Innovative clinical tools to enhance performance and remove complexity
Mapping System Interface Videos
Local Impedance Data
Local impedance indicators define catheter tip to tissue proximity.
Sensor Globe & Temperature Globe
The Sensor Globe & Temperature Globe display real-time temperature feedback during ablation.
TagConnect™
TagConnect™ leverages temperature feedback and distance parameters to draw attention to potential gaps.
Experience the new paradigm for yourself
Recording of Dr. Moussa Mansour presenting Pulsed Field Ablation for AF Using a 9mm Lattice-Tip Catheter PFA Sphere at AF Symposium 2023.5
Safety
0.6%
device-related primary adverse events
Using RF or PF energy6,7
Durability
97%
durable lesions
Per-vein durability at 3 months3,7
Mapping Time
11
mapping minutes
Average time to complete pre-ablation map2
Efficacy
Freedom from atrial arrhythmias
References
1
Anter, Elad, et al. “A lattice-tip temperature-controlled radiofrequency ablation catheter for wide thermal lesions: first-in-human experience with atrial fibrillation.” Clinical Electrophysiology 6.5 (2020): 507-519.
2
Reddy, Vivek Y., et al. “Lattice-tip focal ablation catheter that toggles between radiofrequency and pulsed field energy to treat atrial fibrillation: a first-in-human trial.” Circulation: Arrhythmia and Electrophysiology 13.6 (2020): e008718.Study.
3
Reddy, Vivek Y., et al. “B-PO01-055 ATRIAL FIBRILLATION ABLATION USING A FOCAL LATTICE-TIP CATHETER THAT TOGGLES BETWEEN PULSED FIELD AND RADIOFREQUENCY ENERGY: EFFECT ON THE ESOPHAGUS.” Heart Rhythm 18.8 (2021): S73 4 Confirm Rx ICM K182981 FDA Clearance Letter. 2019.
4
Barkagan M, Leshem E, Rottmann M, Sroubek J, Shapira-Daniels A, Anter E. Expandable lattice electrode ablation catheter. Circ Arrhythm Electrophysiol 2019;12:e007090
5
Pulsed Field Ablation for AF Using a 9mm Lattice-Tip Catheter PFA Sphere Presented at AF Symposium 2023, Boston, MA Moussa Mansour, MD, Massachusetts General Hospital, Boston, MA
6
CR-00014 Rev C. Medtronic data on file.
7
Reddy, Vivek Y., et al. “A focal ablation catheter toggling between radiofrequency and pulsed field energy to treat atrial fibrillation.” JACC: Clinical Electrophysiology (2023): In press.
Brief statement
See the device manual for information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential adverse events. For further information, contact your local Medtronic representative and/or consult the Medtronic website at www.medtronic.eu.
For applicable products, consult instructions for use on 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.