Medtronic’s Linq II Insertable Cardiac Monitor Cleared by FDA for Use in Pediatric Patients

September 20, 2022—Medtronic announced that the Linq II insertable cardiac monitor (ICM) system has received FDA 510(k) clearance for use in pediatric patients aged > 2 years who have heart rhythm abnormalities and require long-term, continuous monitoring.

Jennifer Silva, MD, who is Director of Pediatric Cardiac Electrophysiology at Washington University in St. Louis and St. Louis Children’s Hospital in St. Louis, Missouri, commented in Medtronic’s press release, “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. The data generated from these small monitors can help us better tailor treatment decisions and ongoing management for our patients.”

According to the company, the Linq II ICM system is small (one-third the size of a AAA battery) and wireless. It is designed for patients with abnormal heart rhythms who experience infrequent symptoms, including dizziness, palpitations, syncope, and chest pain, thereby requiring long-term monitoring or ongoing management. The device has a battery life of up to 4.5 years, allows patients to undergo MRI when needed, and, as an implantable device, does not interfere with daily activities such as showering, bathing, or swimming. The latest-generation device was commercialized globally in 2020.

Additionally, Medtronic noted that the Linq II ICM system includes the company’s recently launched AccuRhythm artificial intelligence (AI) algorithms. The algorithms apply AI to heart rhythm event data collected by the Linq II ICM, improving the accuracy of information physicians receive so they can better diagnose and treat abnormal heart rhythms.

The two AI algorithms have been shown to reduce the number of false alerts specific to the most common ICM false alerts—atrial fibrillation and asystole, by 74.1% and 97.4% respectively—while preserving > 99% of true alerts, noted Medtronic.