FDA clears Medtronic’s Linq II for kids 2 and up
Medtronic (NYSE:MDT) announced today that it received FDA 510(k) clearance for its Linq II insertable cardiac monitor (ICM) system.
The Linq II ICM initially received FDA clearance in 2020 for patients aged 21 or older. The clearance announced today allows for use in pediatric patients over two years old who have heart rhythm abnormalities and require long-term, continuous monitoring.
Medtronic said in a news release that Linq II is the first and only ICM to receive such 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,” said Dr. Jennifer Silva, 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.”
Linq II is one-third the size of a AAA battery. The wireless ICM helps patients who experience infrequent symptoms including dizziness, palpitations, syncope (fainting) and chest pain. Those patients require long-term monitoring or ongoing management and Linq II has a battery life of up to 4.5 years.
The device allows patients to undergo MRI when needed and, as an implantable device, it doesn’t interfere with the user’s daily activities.
Enhanced by AI
Linq II also features Medtronic’s AccuRhythm AI algorithms. The algorithms apply artificial intelligence to heart rhythm data collected by the monitor, helping physicians diagnose and treat patients. Medtronic said the algorithms demonstrated reductions in the number of false alerts for AFib (74.1% reduction) and pause (97.4%). The platform also preserves more than 99% of true alerts, the medtech giant said.
Users can choose to use their smartphones with Linq II to automatically transfer device data as well. The data goes to the MyCareLink Heart mobile app using BlueSync Bluetooth communication technology.
“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 Medtronic 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.”