FDA Clears Medtronic's Reveal Linq ICM With TruRhythm Detection

March 13, 2017—Medtronic plc announced US Food and Drug Administration 510(k) clearance for its Reveal Linq insertable cardiac monitor (ICM) with TruRhythm detection, which provides improved accuracy to better identify abnormal heartbeats than the previous Reveal Linq ICM.

Medtronic stated that the Reveal Linq ICM with TruRhythm detection allows physicians to continuously and wirelessly monitor a patient's heartbeat for up to 3 years. The device is approximately one-third the size of a AAA battery (approximately 1 cc). It is placed just beneath the skin through a small incision of < 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; it is MR conditional, allowing patients to undergo magnetic resonance imaging, if needed.

According to the company, Reveal Linq ICM with TruRhythm detection offers 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 (AF) algorithm, which learns and adapts to a patient's heart rhythm over time. Medtronic reported that AF episodes, which are most likely to trigger false positives with ICMs, experienced a 49% reduction in false detections with the Reveal Linq ICM with TruRhythm detection when compared to the Reveal Linq ICM. 

In Medtronic's announcement, James Allred, MD, an electrophysiologist at Cone Health Medical Group Heartcare in Greensboro, North Carolina, commented, "ICMs help physicians find answers for patients at risk for cardiac arrhythmias to better manage a range of patient populations. 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."