FDA Grants New Pediatric Indication for Medtronic Linq II Implantable Cardiac Monitor

The US Food and Drug Administration (FDA) has granted the first pediatric indication for an implantable cardiac monitor to Medtronic. The Linq II Insertable Cardiac Monitor (ICM) System is the first device of its kind to receive 510(k) clearance for use in pediatric patients over 2 years of age who have abnormal heart rhythms and require monitoring continues in the long term.

“For pediatric cardiologists who see many young patients requiring continuous, long-term monitoring for infrequent or unknown cardiac arrhythmias, this expanded indication for the Linq II ICM is critically important,” Jennifer Silva, MD , director of pediatric cardiac electrophysiology at Washington University in St. Louis and St. Louis Children’s Hospital, said in a statement, “The data generated by these small monitors can help us better tailor treatment decisions and ongoing management of our patients.”

Using the Linq II device, physicians will be able to collect actionable data to help diagnose underlying heart conditions and heart rhythms to inform treatment protocols in younger patients. It can also give parents peace of mind knowing that their child’s heart is constantly being monitored and that their doctor will be notified of any abnormal heartbeats.

What is the ICM Linq II device?

The Linq II system is approximately one-third the size of an AAA battery. It is a wireless ICM for patients with abnormal heart rhythms who experience infrequent symptoms including dizziness, palpitations, syncope, and chest pain that require long-term monitoring. Battery life lasts up to 4.5 years. The system also allows patients to undergo magnetic resonance imaging (MRI). Unlike external monitors, the implantable device does not interfere with daily activities such as bathing or swimming.

The system integrates with remote patient management, so patients or their caregivers can use their smartphone to automatically transfer device data using the MyCareLink Heart mobile app via a Bluetooth connection.

The latest version of the Linq System has been implanted in thousands of patients worldwide since it was first released in 2020.

Medtronic recently released AccuRhythm AI algorithms for the Linq II, which applies artificial intelligence (AI) to collected heart rhythm event data. The provider said this helps with the accuracy of the information doctors receive so they can better diagnose and treat abnormal heart rhythms. Medtronic said the two AI algorithms were found to reduce the number of false alerts specific to the most common ICM false alerts — atrial fibrillation (AF) and pause (asystolia) — by 74.1% and 97.4 % respectively,[1,2] while preserving over 99% of true alerts.

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