FDA gives clearance to Medtronic’s LINQ II

The US Food and Drug Administration (FDA) has given clearance to Medtronic’s LINQ II Insertable Cardiac Monitor (ICM) system for use in pediatric patients aged over 2 years.

The LINQ II system is used on patients who have abnormal heart rhythms, leading to symptoms such as dizziness, palpitations, fainting, and chest pain. These patients need long-term monitoring, which the LINQ II provides. It has a battery life of over 4 and a half years, allows patients to take magnetic resonance imaging (MRI), and does not interfere with day-to-day activities due to being small and implantable.

"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. "The data generated from these small monitors can help us better tailor treatment decisions and ongoing management for our patients."

Recently launched AccuRhythm AI algorithms are included in the LINQ II, using artificial intelligence to collect data on heart rhythms. This has been shown to reduce the number of false alerts common in other ICM systems.

Medtronic is a global leader in healthcare technology, having developed insertable cardiac monitors for over 20 years. This FDA approval makes their LINQ II system the first ICM to receive 510k clearance from the FDA for pediatric patients aged over 2 years experiencing abnormal heart rhythms.

"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. "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."

Reference

Medtronic receives FDA clearance for expanded indication of LINQ II™ insertable cardiac monitor for use in pediatric patients ages 2 and older. Medtronic. September 20, 2022. Accessed September 20, 2022.