Next-generation wireless insertable cardiac monitor receives FDA clearance

Medtronic announced the FDA clearance for a new version of its insertable cardiac monitor, designed to minimize the rate of false readings for patients with arrhythmia.

The cardiac monitor (Reveal LINQ with TruRhythm Detection) features updated algorithms that reduce inaccurate results including false bradycardia by 95% and false pause by 47%, compared with the predecessor device (Reveal LINQ), according to a press release.

Another algorithm learns a patient’s heart rhythm and was shown to decrease the rate of false positives for atrial fibrillation by 49%, the company stated in the release.

“[Medtronic] 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,” Nina Goodheart, vice president and general manager of the Patient Monitoring and Diagnostics business at Medtronic, said in the release.

The MRI-compatible cardiac monitor, about one-third the size of a AAA battery, is inserted below the skin on the left-hand side of the chest through a 1 cm incision. Once implanted, the device sends data wirelessly via a bedside monitor to a network for physicians to monitor their patients’ status, according to the release.

“[Insertable cardiac monitors] help physicians find answers for patients at risk for cardiac arrhythmias to better manage a rage of patient populations,” James Allred, MD, an electrophysiologist at Cone Health Medical Group Heartcare in Greensboro, North Carolina, said in the release. “The enhancements with the Reveal LINQ [insertable cardiac monitor] with TruRhythm Detection make it smarter by streamlining device data review so physicians can make decisions more accurately and quickly for patients.” – by Darlene Dobkowski

Disclosure: Goodheart is an employee of Medtronic. Allred reports consulting for Medtronic and speaking for Janssen.