Insertable Cardiac Monitors

Insertable cardiac monitors (ICMs) are small implanted devices that let you continuously monitor your patients’ cardiac rhythms over years. ICMs provide the time needed to diagnose even the most difficult-to-detect arrhythmias, and eliminate the need for bulky external monitors that can interfere with your patients’ daily lives. Our ICM technology is designed to help you clearly and confidently diagnose arrhythmias with fewer interruptions to patients’ daily lives.

References

^®Bluetooth and the Bluetooth figure mark are registered trademarks of Bluetooth SIG, Inc.

1. Design Validation Report and Trace Matrix, Insertable Cardiac Monitor (ICM) System document 60098828. April 2019.
2. PiorkowskiC, et al. Early real-world adoption of mobile remote monitoring using the Confirm Rx Insertable Cardiac Monitor. Poster presented at: APHRS; 2018.

Indications, Safety & Warnings

Confirm Rx™

Model DM3500
Insertable Cardiac Monitor

Indications: The Confirm Rx™ ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation. The Confirm Rx™ ICM has not been specifically tested for pediatric use.

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

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, contraindications, warnings, precautions and potential adverse events.

Additional information: Clinicians must log onto Merlin.net™ Patient Care Network to view transmissions from patients’ Confirm Rx™ ICM. On Merlin.net™ PCN they can configure transmission schedules and enable or disable features on a patient’s myMerlin™ mobile app. Review of transmissions is dependent on the clinician and may not happen immediately following delivery of such transmissions.

Limitations: Patients may use their own Apple‡ or Android‡ mobile device to transmit information from their Confirm Rx™ ICM using the myMerlin™ mobile app. To do so the device must be powered on, app must be installed, Bluetooth® wireless technology enabled and data coverage (cellular or WiFi‡) available. The myMerlin™ mobile app provides periodic patient monitoring based on clinician configured settings. Data is resent if the transmission was not sent successfully. However, there are many internal and external factors that can hinder, delay, or prevent acquisition and delivery of ICM and patient information as intended by the clinician. These factors include: patient environment, data services, mobile device operating system and settings, ICM memory capacity, clinic environment, schedule/configuration changes, or data processing.

An Abbott mobile transmitter is available for patients without their own compatible mobile device.