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Assert-IQ™ Insertable Cardiac Monitor (ICM) Cleared by the FDA

Abbott Cardiac Rhythm Management | May 31, 2023

At the forefront of cardiac care, we here at Abbott are excited to announce that our Assert-IQ™ Insertable Cardiac Monitor (ICM) has been cleared by the FDA. 

Through this device, we have transformed the detection and management of arrhythmias and have engineered a new experience that provides the best diagnostic solution for your staff and patients. This solution is focused on the areas most meaningful for cardiac monitoring:

• FEWER FALSE POSITIVES
• REDUCED DATA BURDEN
• SIMPLIFIED CLINIC WORKFLOW WITH REMOTE PROGRAMMING
• DATA-DRIVEN INSIGHTS
  

See how the Assert-IQ ICM is designed to outperform and built to outlast:

The Assert-IQ ICM’s advanced algorithms reduce false detections by 98.7% for AF and Pause while maintaining 97.7% of true EGMs.^1-3 Our AF algorithm reduces data burden by 21% compared to the latest version of LINQ II^‡*,1,4,5 and utilizes a five-step AF detection discriminator that focuses on R-R interval patterns and P-Waves in EGMs to verify if an event is true or false.

As the longest lasting Bluetooth^®-enabled ICM^† device, Assert-IQ ICM operates at full functionality beyond six years. Plus, it features remote programmability capabilities that make it easier to adjust parameters, saving valuable time for you and your patients.

Here’s how it works:

• Advanced Bluetooth^® technology checks in every 20 seconds with the connected device to capture, encrypt and transfer patient data to the Merlin.net™ Patient Care Network (PCN) via a connected mobile device with the myMerlin™ Mobile App.
• A reprogramming request can be initiated and transmitted to a patient through the app quickly and easily – all without the need for an office visit.

To meet the evolving needs of patients using remote monitoring with an ICM, we are offering two battery life options: 

Additional IQ Insights are another exciting new feature of our Assert-IQ™ ICM. These sensors help you make data-driven decisions faster and more confidently. Some of the diagnostics the new sensors capture include: 
 

Assert-IQ ICM provides the best diagnostic solutions for your staff and for your patients who require long-term monitoring. Learn more by visiting the Assert-IQ ICM website and reading this press release.

*As of 12.31.22, LINQ II^‡ with AccuRhythm^‡ AI. EGM burden comparison is based on two independent, random, real-world data sets. Patient characteristics and device programming may differ.

** Data on File. Abbott - Report 90984075.

†As of 12.31.22. Reveal LINQ^‡ User Manual, LINQ II^‡ User Manual, Lux Dx^‡ User Manual, Biomonitor III^‡ User Manual, Biomonitor IIIm^‡ User Manual

™ 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.

References:

1. Gopinathannair R, Lakkireddy D, Manyam H, et al. Improving the Specificity of Atrial Fibrillation and Tachycardia Detection in an Insertable Cardiac Monitor. Presented at Heart Rhythm Society (HRS); San Francisco, USA; 2022.
2. Afzal MR, Gopinathannair R, Manyam H, et al. Development and Evaluation of a New Algorithm Enhancement to Improve Specificity of Pause Detection in an Insertable Cardiac Monitor. Presented at Heart Rhythm Society (HRS); San Francisco, USA; 2022.
   
3. Data on File. Abbott - Report SJM-CFM-0919-0163.
   
4. Radtke, et al. Artificial Intelligence Enables Dramatic Reduction of False Atrial Fibrillation Alerts from Insertable Cardiac Monitors. Presented at Heart Rhythm Society (HRS); Boston, USA; Aug 2021.
   
5. Data on File. Abbott - Report 90986479; AF EGM Burden Reduction in Assert IQ ICM.
   
6. Manyam H, Afzal MR, Gopinathannair R, et al. Evaluation of A Novel Premature Ventricular Contraction Detection Algorithm in an Insertable Cardiac Monitor. Presented at Heart Rhythm Society (HRS); San Francisco, USA; 2022.
   
7. Abbott. Assert-IQ ICM User Manual.
   
8. 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
   
9. 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
   
10. 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
11. Biotronik. Technical Manual BioMonitor III^‡. Updated December 10, 2020. Accessed January 17, 2023. https://manuals.biotronik.com/emanuals-professionals/?country=US&product=ImplCardMon/BioMonitor3/BioMonitor3_US 
12. Biotronik. Technical Manual BioMonitor IIIm^‡. Updated December 10, 2020. Accessed January 17, 2023. https://manuals.biotronik.com/emanuals-professionals/?country=US&product=ImplCardMon/BioMonitor3m/BioMonitor3m_US