Medtronic’s tiny heart monitor gets more accurate, gains FDA nod

The Reveal Linq insertable cardiac monitor is about one-tenth the size of its predecessor, the Reveal XT. (Medtronic)

Medtronic’s tiny, insertable cardiac monitor has gotten an upgrade: The FDA cleared a new version of the Reveal Linq, which now includes algorithms that ramp up the implant’s accuracy in reporting abnormal heartbeats.

The Reveal Linq, a cardiac monitor one-third the size of an AAA battery, is implanted in the upper left side of the chest. It transmits data wirelessly to a patient bedside monitor and its battery life allows it to monitor abnormal heart rhythms for up to three years.

When compared to the original Reveal Linq, the device with TruRhythm Detection cut down on false reports of bradycardia (slow heartbeat) by 95% and reduced false pause detections by 47%, Medtronic said in a statement, citing internal data.

The new device also includes an algorithm for atrial fibrillation—an irregular heart rate—that learns a patient’s heart rhythm over time, tamping down on false detections of AF episodes, Medtronic said.

"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,” said Nina Goodheart, vice president and general manager of Medtronic’s patient monitoring and diagnostics unit, in the statement.

Medtronic rolled out the original Reveal Linq in 2014 and reported last summer data from a real-world study showing the device was better at detecting AF than previously thought. Improving the monitor’s accuracy means that phyisicians spend less time reviewing cardiac data, Medtronic said.

"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., an electrophysiologist at Cone Health Medical Group Heartcare, in the statement. "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."