FDA has approved Medtronic’s Insertable Cardiac Monitor to allow improved accuracy to better identify abnormal heartbeats

Medtronic announced U.S. Food and Drug Administration (FDA) 510(k) clearance for its Reveal LINQ(TM) Insertable Cardiac Monitor (ICM) with TruRhythm(TM) Detection, an advanced cardiac monitor offering improved accuracy to better identify abnormal heartbeats.

An insertable cardiac monitor is a small device that continuously monitors heart rhythms and records them automatically and manually by using a hand-held patient assistant. The device is inserted just beneath the skin in the chest area during a simple procedure.

An insertable cardiac monitor is programmed to continuously monitor your heart’s activity in the form of an electrocardiogram (ECG). When a fainting spell occurs, you or your family member should immediately place the hand-held patient assistant over the cardiac monitor and press the record symptoms (heart-shaped) button.

Image result for Medtronic won FDA clearance for its Reveal LINQ Insertable Cardiac Monitor with TruRhythm Detection.

This triggers the device to record the heart’s rhythm before, during, and after the unexplained fainting spell. An insertable cardiac monitor can also be programmed to record abnormal heart rhythms automatically. Your doctor has a better possibility of determining the cause of your fainting by reviewing the information recorded by your insertable cardiac monitor and comparing to what you may have marked using your patient assistant.

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(TM) 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.

Reveal LINQ ICM System

“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. “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.”

In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services of the highest quality that deliver clinical and economic value to healthcare consumers and providers around the world.

 

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