Abbott ASSERT-IQ EL Plus Insertable Cardiac Monitor

AF PATIENT CARE BEYOND DIAGNOSIS

Extend your monitoring using the longest lasting Bluetooth® ICM1-9 with no compromises: Assert-IQ EL+ ICM.

Following catheter ablation, recurrent AF episodes are ~3X more likely to be asymptomatic compared to symptomatic ones.^10-14
Patients with AF recurrence face an increased risk of AF-related thromboembolic events, even if asymptomatic.¹⁶
Up to 46% of patients experience very late AF recurrence at 5 years.¹⁵

LOOK BEYOND 3-4 YEARS

ASSERT-IQ EL+ IS THE ONLY ICM FOR LONGER TERM (6+ YEARS) MONITORING FOR AF MANAGEMENT.^1-9

LONG-TERM MONITORING WITH AN ICM IS A MORE EFFECTIVE WAY TO MANAGE AF.

In post-AF ablation patients with and without insertable cardiac monitoring, the use
of ICMs is associated with:¹⁶

* Cost savings is based on 1.4–4 years post-AF ablation. Mean cost per patient is based on Mansour et al. with an inflation adjustment applied.
** Composite of: acute ischemic stroke, transient ischemic attack, systemic embolism, major bleeds, AF- and HF-related hospitalizations, and death.^§

PROFESSIONAL SOCIETIES SUPPORT

LONG-TERM MONITORING WITH AN ICM. ^{15, 17}

For post-ablation patients in whom discontinuation of an oral anticoagulant (OAC) is considered, an ICM has been shown to detect more arrhythmia recurrences than short-term ECG monitors according to a 2017 consensus statement from:

• Heart Rhythm Society
• European Heart Rhythm Association
• European Society of Cardiology

REFERENCES:

1. Abbott. Assert-IQ ICM User Manual.
2. Medtronic. REVEAL LINQ‡ LNQ11 Insertable Cardiac Monitor and Patient Assistant PA96000 Clinician Manual. Updated August 26, 2015. Accessed January 17, 2023.
   https://manuals.medtronic.com/content/dam/emanuals/crdm/CONTRIB_215651.pdf
3. Medtronic. LINQ II‡ LNQ22 Insertable Cardiac Monitor Clinician Manual. Updated September 01, 2022. Accessed January 17, 2023.
   https://manuals.medtronic.com/content/dam/emanuals/crdm/M032283C001B_view.pdf
4. Boston Scientific. User’s Manual, LUX-Dx‡ Insertable Cardiac Monitor System M301, 2925, 2935. Updated July 2020. Accessed January 17, 2023.
   https://www.bostonscientific.com/content/dam/Manuals/us/current-rev-en/92216689-002_LUX-Dx_UM_en_S.pdf
5. Boston Scientific. User’s Manual, LUX-Dx II/II+‡ Insertable Cardiac Monitor System M302, M312, 2925, 2929, 2935, 2939. Updated August 2023. Accessed February 23, 2024.
   https://www.bostonscientific.com/content/dam/elabeling/crm/51583079-001_LUX-Dx_ICM_UM_en_S.pdf
6. Biotronik. Technical Manual BioMonitor III‡. Updated December 10, 2020. Accessed January 17, 2023. https://manuals.biotronik.com/emanualsprofessionals/country=US&product=ImplCardMon/BioMonitor3/BioMonitor3_US
7. Biotronik. Technical Manual BioMonitor IIIm‡. Updated December 10, 2020. Accessed January 17, 2023. https://manuals.biotronik.com/emanualsprofessionals/country=US&product=ImplCardMon/BioMonitor3m/BioMonitor3m_US
8. Biotronik. Technical Manual BIOMONITOR IV‡. Updated July 17, 2023. Accessed February 23, 2024. https://manuals.biotronik.com/emanuals-professionals/?country=US&product=ImplCardMon/BioMonitor4/BioMonitor4_US
9. Data on File. Abbott – Report 90984075.
10. Balabanski T, Brugada J, Arbelo E, et al. Impact of Monitoring on Detection of Arrhythmia Recurrences in the ESC-EHRA EORP Atrial Fibrillation Ablation Long-term Registry.
    Europace. 2019;21(12):1802-1808. doi:10.1093/europace/euz216.
11. Hindricks G, Piorkowski C, Tanner H, et al. Perception of Atrial Fibrillation Before and After Radiofrequency Catheter Ablation: Relevance of Asymptomatic Arrhythmia Recurrence.
    Circulation. 2005;112(3):307-313. doi:10.1161/CIRCULATIONAHA.104.518837.
12. Schirdewan A, Herm J, Roser M, et al. Loop Recorder Detected High Rate of Atrial Fibrillation Recurrence after a Single Balloon- or Basket-Based Ablation of Paroxysmal Atrial
    Fibrillation: Results of the MACPAF Study. Frontiers in Cardiovascular Medicine. 2017;4:4. DOI 10.3389/fcvm.2017.00004.
13. Takigawa M, Takahashi A, Kuwahara T, et al. Long-term Follow-up After Catheter Ablation of Paroxysmal Atrial Fibrillation: The Incidence of Recurrence and Progression of Atrial Fibrillation. Circulation Arrhythmia and Electrophysiology. 2014;7(2):267-273. doi:10.1161/CIRCEP.113.000471.
14. Verma A, Champagne J, Sapp J, et al. Discerning the Incidence of Symptomatic and Asymptomatic Episodes of Atrial Fibrillation Before and After Catheter Ablation (DISCERN AF): A
    Prospective, Multicenter Study. JAMA Internal Medicine. 2013;173(2):149-156. doi:10.1001/jamainternmed.2013.1561.
15. Calkins H, Hindricks G, Cappato R, et al. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE Expert Consensus Statement on Catheter and Surgical Ablation of Atrial Fibrillation. Very Late Recurrence (More Than 1 Year) After AF Ablation. Heart Rhythm. 2017;14(10):e275-e444. doi:10.1016/j.hrthm.2017.05.012.
16. Mansour MC, Gillen EM, Garman A, et al. Healthcare Utilization and Outcomes in Atrial Fibrillation Ablation Patients With and Without Insertable Cardiac Monitoring. European Heart Journal. 2020;41:545. https://dialog.proquest.com/professional/docview/2490816673?accountid=152602. doi: http://dx.doi.org/10.1093/ehjci/ehaa946.0545
17. Joglar JA, Chung MK, Armbruster AL, et al. 2023 ACC/AHA/ACCP/HRS Guideline for the Diagnosis and Management of Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Journal of the American College of Cardiology (JACC). 2024;83(1):109 279. doi:10.1016/j.
    jacc.2023.08.017
18. Lakkireddy DR, Garg J, Ahmed A, et al. Lb-456091-2 Dynamic Data Driven Management of Atrial Fibrillation Using Implantable Cardiac Monitors – the Monitor AF Study. Heart Rhythm. 2023;20(7):1085-1086. doi:10.1016/j.hrthm.2023.04.041.

^§Presence of an ICD-9/10 diagnosis code for AF or HF in the primary diagnostic position on the inpatient claim were used to calculate total costs.

Rx Only

Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.

Indications for Use: The Assert-IQ™ ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms that may be cardiac-related such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias such as bradycardia, tachycardia, and sinus pauses. The Assert-IQ ICM is also indicated for patients who have been previously diagnosed with atrial fibrillation (AF) or who are susceptible to developing AF.
The Assert-IQ ICM is intended to be inserted subcutaneously in the left pectoral region, also described as the left anterior chest wall. The Assert-IQ ICM has not been specifically tested for pediatric use.

Intended Use: The Assert-IQ ICM is intended to help physicians and clinicians monitor, diagnose and document the heart rhythm in patients who are susceptible to cardiac arrhythmias and unexplained symptoms by detecting arrhythmias and transmitting data for review.

Contraindications: There are no known contraindications for the insertion of the Assert-IQ ICM. However, the patient’s particular medical condition may dictate whether or not a subcutaneous, chronically inserted device can be tolerated.

Potential Adverse Events: Possible adverse events (in alphabetical order) associated with the device, include the following: allergic reaction, bleeding, chronic nerve damage, erosion, excessive fibrotic tissue growth, extrusion, formation of hematomas or cysts, infection, keloid formation and migration.
Refer to the User’s Manual for detailed indications for use, contraindications, warnings, precautions and potential adverse events. An Abbott mobile transmitter is available for patients without their own compatible mobile device.
™Indicates a trademark of the Abbott group of companies.
‡ Indicates a third-party trademark, which is property of its respective owner.
Bluetooth and Bluetooth logo are registered trademarks of Bluetooth SIG, Inc.

Abbott
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Tel: +1 818 362 6822
Abbott.com
© 2024 Abbott. All Rights Reserved.
MAT-2410856 v1.0 | Item approved for U.S. use.

Why would you treat your AF patients differently?
Continuous monitoring is relied upon for disease management in diabetes, hypertension, and heart failure.¹⁸
Scan the QR code to learn more or visit cardiovascular.abbott/AssertIQ

Documents / Resources

Abbott ASSERT-IQ EL Plus Insertable Cardiac Monitor [pdf] Owner's Manual ASSERT-IQ EL Plus, ASSERT-IQ EL Plus Insertable Cardiac Monitor, Insertable Cardiac Monitor, Cardiac Monitor, Monitor

References

• User Manual