Medtronic receives FDA clearance for expanded paediatric indication of Linq II cardiac monitor

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Medtronic has announced that the Linq II insertable cardiac monitor (ICM) system has received 510(k) clearance from the US Food and Drug Administration (FDA) for use in paediatric patients over the age of two who have heart rhythm abnormalities and require long-term, continuous monitoring.

“For paediatric 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 (Washington University in St Louis and St Louis Children’s Hospital, St Louis, USA). “The data generated from these small monitors can help us better tailor treatment decisions and ongoing management for our patients.”

The Linq II system is a small wireless ICM 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 Linq II ICM, which has a battery life of up to 4.5 years, allows patients to undergo magnetic resonance imaging (MRI) when needed, and, as an implantable device, does not interfere with daily activities such as showering, bathing, or swimming. The latest-generation device has been implanted in thousands of patients globally since it was first commercialised in 2020.

The system also includes the recently launched AccuRhythm AI algorithms. The two AI algorithms have shown to reduce the number of false alerts specific to the most common ICM false alerts—atrial fibrillation (AF) and pause (asystole)— by 74.1% and 97.4% respectively, while preserving more than 99% of true alerts, Medtronic said in a press release.


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