Medtronic’s LINQ II ICM OK’ed for Kids 2 and Up

Medtronic has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its LINQ II insertable cardiac monitor (ICM) for used in pediatric patients over two with heart rhythm abnormalities needing long-term, continuous monitoring.
 
According to the company, LINQ II is the first and only ICM with this clearance.
 
“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,” Jennifer Silva, M.D., director of pediatric cardiac electrophysiology at Washington University in St. Louis and St. Louis Children’s Hospital, told the press. “The data generated from these small monitors can help us better tailor treatment decisions and ongoing management for our patients.”
 
About one-third the size of a AAA battery, the wireless LINQ II ICM is for patients with abnormal heart rhythms with infrequent symptoms like dizziness, palpitations, syncope (fainting) and chest pain, thus requiring long-term monitoring or ongoing management.
 
Its battery life can last up to 4.5 years under nominal settings and patients using it can undergo MRI scans when needed. LINQ II was first commercialized in 2020.
 
“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 Medtronic’s Cardiovascular Diagnostics and Services business. “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.”
 
LINQ II also features Medtronic’s recently launched AccuRhythm AI algorithm, which applies AI to collected heart rhythm event data to improve accuracy of information physicians receive. The two AI algorithms have shown to reduce the number of false alerts specific to the most common ICM false alerts—AFib and asystole.