FDA clears Reveal LINQ Insertable Cardiac Monitor with TruRhythm Detection

207

The US Food and Drug Administration (FDA) has given 510(k) clearance to Medtronic for its Reveal LINQ Insertable Cardiac Monitor (ICM) with TruRhythm Detection.

A company release states that the Reveal LINQ ICM with TruRhythm Detection offers exclusive algorithms that result in a 95% reduction in false bradycardia episodes and a 47% reduction in false pause episodes when compared with its predecessor, the Reveal LINQ ICM. The device also features a self-learning atrial fibrillation algorithm, which learns and adapts to a patient’s heart rhythm over time.  Atrial fibrillation episodes, which are most likely to trigger false positives with insertable cardiac monitors, experienced a 49% reduction in false detections with the Reveal LINQ ICM with TruRhythm Detection when compared to the Reveal LINQ ICM.1

“Insertable cardiac monitors help physicians find answers for patients at risk for cardiac arrhythmias to better manage a range of patient populations,” says James Allred, electrophysiologist at Cone Health Medical Group Heartcare in Greensboro, USA. “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 1cm 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.

1 TruRhythm Detection Algorithms. Medtronic data on file. 2017.