Medtronic has announced the CE Mark and the US Food and Drug Administration (FDA) 510(k) approvals, and the global launch of its Reveal LINQ insertable cardiac monitor (ICM) system.
Medtronic claims that Reveal LINQ is the smallest implantable cardiac monitoring device available for patients. The device is approximately one-third the size of a AAA battery (~1 cc), making it more than 80% smaller than other ICMs.
The miniaturized monitoring system allows physicians to continuously and wirelessly monitor a patient’s heart for up to three years, with 20% more data memory than its larger predecessor, Reveal XT.
Featuring a MyCareLink patient monitor, the new device transmits patients’ cardiac device diagnostic data to their clinicians from nearly any location in the world. Carelink network of the device provides remote monitoring and physicians can request notifications to alert them if their patients have had cardiac events.
Medtronic has designed the Reveal LINQ ICM for patients who experience symptoms such as dizziness, palpitation, syncope (fainting) and chest pain that may suggest a cardiac arrhythmia, and for patients at increased risk for cardiac arrhythmias.
The Reveal LINQ ICM is placed just beneath the skin through a small incision of less than 1cm in the upper left side of the chest using a minimally invasive insertion procedure. The device is MR-conditional, allowing patients to undergo magnetic resonance imaging if needed.
Medtronic senior vice president and Cardiac Rhythm Disease Management business president Pat Mackin noted this miniaturized monitoring system is the result of many years of product development work from engineers focused on shrinking the size of medical devices while maintaining their power and improving benefits for patients.
"This is game-changing technology for patients who need cardiac monitoring, and we look forward to providing them with the most technologically advanced and minimally invasive approach possible," Mackin added.
Image: Medtronic’s Reveal XT insertable cardiac monitor. Photo: Courtesy of Medtronic Inc.