Medtronic Takes Linq II to the Pediatric Population with New Indication
The Dublin-based company won clearance for its continuous long-term care monitor to be used in patients over the age of two, who have heart rhythm abnormalities and require long-term, continuous monitoring.
September 20, 2022
Medtronic is bringing one of its most innovative technologies to pediatrics.
The Dublin-based company said it won a nod from FDA to have the Linq II Insertable Monitor to be used in pediatric patients over the age of two who have heart rhythm abnormalities and require long-term, continuous monitoring.
The LINQ II system is a small (one-third the size of a AAA battery), wireless ICM for patients with abnormal heart rhythms who experience infrequent symptoms including dizziness, palpitations, syncope (fainting) 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.
“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, M.D., 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."
Medtronic first won a nod from FDA for the device in 2020. The Linq II Insertable Monitor also ended up winning the best-in-show award during the MDEAs in 2021.
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