Medtronic’s new cardiac monitor receives FDA approval

Twitter icon
Facebook icon
LinkedIn icon
e-mail icon
Google icon

The U.S. Food and Drug Administration (FDA) approved Medtronic’s Reveal LINQ Insertable Cardiac Monitor with TruRhythm Detection, designed to accurately identify abnormal heartbeats.

This model of the device runs on algorithms that resulted in a 95 percent reduction in false bradycardia episodes and a 47 percent reduction in false cardiac pauses compared to its predecessor, according to a press release from Medtronic. The TruRhythm also has a self-learning atrial fibrillation algorithm that adapts to a patient’s heart rhythm over time.

"Insertable cardiac monitors help physicians find answers for patients at risk for cardiac arrhythmias to better manage a range of patient populations," said James Allred, MD, an electrophysiologist at Cone Health Medical Group Heartcare in Greensboro, North Carolina, in a statement. "The enhancements with the Reveal LINQ ICM with TruRhythm Detection make it smarter by streamlining device data review so physicians can make decisions more accurately and quickly for patients."

The device can be used by a patient for up to three years before needing replacement, is about a third of the size of a AAA battery and wirelessly sends data to a bedside monitor connected to the Medtronic CareLink network. Additionally, it is safe to undergo MRI.

"For nearly twenty years, Medtronic has led innovation in cardiac monitoring, including Reveal(TM), the world's first loop recorder, and Reveal LINQ, the world's smallest ICM," said Nina Goodheart, vice president and general manager of the Patient Monitoring & Diagnostics business at Medtronic, in a statement. "We collaborated with hundreds of clinicians and analyzed more than 50,000 electrocardiograms allowing us to pinpoint how we could redesign our algorithms to improve detection specificity, without compromising sensitivity."