FDA Clears Medtronic’s Insertable Cardiac Monitor with TruRhythm Detection

Medtronic plc today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for its Reveal LINQ Insertable Cardiac Monitor (ICM) with TruRhythm Detection, an advanced cardiac monitor offering improved accuracy to better identify abnormal heartbeats.
 
Reveal LINQ ICM with TruRhythm Detection offers exclusive algorithms that result in a 95 percent reduction in false bradycardia (slow heartbeat) episodes and a 47 percent reduction in false pause (brief absence of cardiac activity) episodes when compared with its predecessor, the Reveal LINQ ICM. The device also features a self-learning atrial fibrillation (AF—an irregular and often very fast heart rate) algorithm, which learns and adapts to a patient’s heart rhythm over time. AF episodes, which are most likely to trigger false positives with ICMs, experienced a 49 percent reduction in false detections with the Reveal LINQ ICM with TruRhythm Detection when compared to the Reveal LINQ ICM.¹
 
“ICMs help physicians find answers for patients at risk for cardiac arrhythmias to better manage a range of patient populations,” said James Allred, M.D., electrophysiologist at Cone Health Medical Group Heartcare in Greensboro, N.C. “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.”
 
Reveal LINQ ICM with TruRhythm Detection, which allows physicians to continuously and wirelessly monitor a patient’s heartbeat for up to three years, is approximately one-third the size of an AAA battery (~1 cc). It is placed just beneath the skin through a small incision of less than 1 cm in the upper left side of the chest, using a minimally invasive procedure, and its presence is often nearly undetectable to the naked eye once the incision has healed. The device communicates wirelessly with a patient bedside monitor that uploads device data to the Medtronic CareLink network; it is MR-Conditional, allowing patients to undergo magnetic resonance imaging (MRI), if needed.
 
“For nearly twenty years, Medtronic has led innovation in cardiac monitoring, including Reveal, 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. “We collaborated with hundreds of clinicians and analyzed more than 50,000 ECGs allowing us to pinpoint how we could redesign our algorithms to improve detection specificity, without compromising sensitivity.”
 
Reference
¹TruRhythm Detection Algorithms. Medtronic data on file. 2017.