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LINQ II ICM Receives Historic FDA Clearance for Children Aged 2 Years and Older

The LINQ II insertable cardiac monitor (ICM) has become the first continuous, long-term ICM cleared by the US Food and Drug Administration (FDA) for use in pediatric patients, according to a statement from Medtronic.

Announced on September 20, the FDA’s 510(k) clearance of the small, wireless ICM, which has a battery life of up to 4.5 years, is for use in pediatric patients over the age of 2 years who have heart rhythm abnormalities and require long-term, continuous monitoring.

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

Billed by Medtronic as an ICM that is one-third the size of AAA battery for patients with heart rhythms who experience infrequent symptoms including dizziness, palpitations, syncope, and chest pain, the LINQ II received clearance from the FDA for adult populations in 2020. With the latest clearance, the LINQ II ICM is now the first and only ICM to carry an indication for pediatric patients over the age of 2 with heart rhythm abnormalities requiring long-term, continuous monitoring.

In their statement announcing the clearance, Medtronic pointed out the LINQ II ICM system also includes the AccuRhythm AI algorithms to improve the accuracy of information providers receive ed to improve diagnosis and treatment. Further in the statement, Medtronic points out dual AI algorithms have been shown to reduce the number of false alerts specific to ICMs while reserving more than 99% of true alerts.

Medtronic also pointed out the LINQ II ICM system has the ability to automatically transfer data to smartphones via the MyCareLink Heart mobile app. According to Medtronic, more than 1.7 million patients have already received a Medtronic ICM.

“As a result of this milestone, physicians will be able to provide actionable data to help diagnose underlying heart conditions and define treatment protocols in our younger patients with abnormal heart rhythms,” said Julie Brewer, president of the Cardiovascular Diagnostics and Services business, which is part of the Cardiovascular Portfolio at Medtronic. “And parents can have peace of mind knowing their child’s heart is being monitored continuously, and their doctor will be notified of abnormal heartbeats.”