The US FDA has granted 510(k) clearance for Medtronic’s Reveal Linq Insertable Cardiac Monitor (ICM) with TruRhythm Detection. The device is an advanced cardiac monitor offering improved accuracy to better identify abnormal heartbeats, according to the company.
The device allows physicians to continuously and wirelessly monitor a patient’s heartbeat for up to three years and 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. The device communicates wirelessly with a patient bedside monitor that uploads device data to the Medtronic CareLink network.
The device 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, according to Medtronic.
The device also features a self-learning atrial fibrillation (AF) 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% reduction in false detections with the new product when compared to its predecessor, Medtronic reported.
“ICMs help physicians find answers for patients at risk for cardiac arrhythmias to better manage a range of patient populations,” said James Allred, MD, electrophysiologist at Cone Health Medical Group Heartcare in Greensboro, NC. “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.”