Medtronic (NYSE:MDT) said today it won FDA 510(k) clearance for its next-gen Reveal Linq insertable cardiac monitor with TruRhythm Detection.
The Linq ICM with TruRhythm Detection offers exclusive algorithms which the Fridley, Minn.-based company said resulted in a 95% reduction in false bradycardia episodes and a 47% reduction in false pause episodes compared with the previous-gen version of the device.
“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,” Dr. James Allred of Greensboro, N.C.’s Cone Health Medical Group Heartcare said in a prepared statement.
The Reveal Linq device is designed to be implanted beneath the skin on the upper left side of the chest for monitoring patients experiencing dizziness, palpitation, fainting or syncope, chest pain and cardiac arrhythmias. Billed as the world’s smallest cardiac monitor, it’s about ⅓ the size of a triple-A battery and is designed to work for 3 years using the company’s CareLink network.
Medtronic said that the Reveal Linq ICM is MR-conditional, allowing patients to undergo magnetic resonance imaging if necessary. The system also includes the MyCareLink patient monitor which allows for remote monitoring and the transmission of patient data to clinicians from any location.
“For nearly 20 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. 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,” patient monitoring & diagnostics biz GM Nina Goodheart said in a press release.
Last September, Medtronic launched the Linq device in Japan after winning approval from the Ministry of Health, Labor & Welfare.
Its approval in Japan covers its use for monitoring unexplained syncope and cryptogenic stroke, the company said. Medtronic said the MHLW also granted reimbursement approval for the device.
