Medtronic this week received regulatory approval for the use of an implantable cardiac monitor in pediatric patients, giving doctors and parents greater peace of mind about the device’s safety.
On Tuesday, the US Food and Drug Administration said Medtronic’s Linq II device, already approved for adults, could be implanted in kids age 2 and older. Many doctors were already using Linq II with children, but the FDA clearance offers additional safety assurance to providers and caretakers.
Pediatric cardiologists welcomed the news of FDA clearance.
“There is no implantable device that has been FDA approved so far. This is a step in the right direction,” said Dr. Varun Aggarwal, who specializes in interventional pediatric cardiology for the M Health Fairview University of Minnesota Medical Center.
Aggarwal, who is also an assistant professor of the Department of Pediatrics at the University of Minnesota, is among those doctors already using Linq II in the pediatric population.
Deploying a device for an application not approved by the FDA is considered an “off-label” use. Aggarwal said it’s fairly common for pediatric doctors to use devices off-label because so few technologies have been specifically approved for younger patients.
Linq II “has been used in pediatrics … it’s a good device,” Aggarwal said.
The device is designed for cardiac patients with infrequent, periodic symptoms — such as dizziness or heart palpitations — that require long-term management and monitoring. The wireless device is about one-third the size of a AAA battery and is inserted just beneath the skin. Linq’s own battery can last for up to four and a half years.
“We think that our youngest patients, who also can sometimes have unexplained suspected arrhythmias, are the perfect candidates for this type of technology,” said Julie Brewer, Medtronic’s president of Cardiovascular Diagnostics and Services, in an interview.
The FDA approved Linq II for adults in 2020. Medtronic received separate FDA clearance in 2021 for its artificial intelligence algorithm used for cardiac monitoring. Medtronic’s AI focuses on reducing false alerts from the monitor, most commonly caused by atrial fibrillation or a pause in the heartbeat. The AI algorithm is shaped by Medtronic’s vast library of heart monitoring data.
“We really are focusing on data and how we’re turning data into the right therapy for patients,” Brewer said.
With Linq II, a smartphone can be used to transfer monitoring data through a mobile app. There is also the option of using a home monitor — which could, for example, be set on a nightstand.
The lack of medical devices for pediatric patients is an often-discussed concern. The FDA held a conference in 2018 to create strategies for bolstering innovation and development within the pediatric category. The FDA has pledged to support the development and availability of approved pediatric devices.
One challenge is that children are smaller and their bodies change throughout childhood.
The FDA defines pediatric patients as being 21 years old or younger.
“We wanted to make sure we did the work necessary to demonstrate the safety in this population so that we can hopefully then reach more patients,” Brewer said.