February 20, 2014 — Medtronic Inc. announced U.S. Food and Drug Administration (FDA) 510(k) clearance, CE marking and the global launch of its Reveal Linq Insertable Cardiac Monitor (ICM) System. Medtronic calls it the smallest implantable cardiac monitoring device available for patients.
The Reveal Linq ICM is approximately one-third the size of a AAA battery (~1 cc), making it more than 80 percent smaller than other ICMs. The device is part of a system that allows physicians to continuously and wirelessly monitor a patient’s heart for up to three years, with 20 percent more data memory than its larger predecessor, Reveal XT.
The system provides remote monitoring through the CarelinkNetwork in which physicians can request notifications to alert them if their patients have cardiac events. The Reveal Linq ICM is indicated for patients who experience symptoms such as dizziness, palpitation, syncope and chest pain that may suggest a cardiac arrhythmia, and for patients at increased risk for cardiac arrhythmias.
Placed just beneath the skin through a small incision of less than 1 cm in the upper left side of the chest, the Reveal Linq ICM is often nearly invisible to the naked eye once inserted. The device is placed using a minimally invasive insertion procedure, which simplifies the experience for both physicians and their patients. The Reveal Linq ICM is MR-Conditional, allowing patients to undergo magnetic resonance imaging (MRI) if needed.
The Reveal Linq system also includes the new MyCareLink Patient Monitor. That is a simplified remote monitoring system with global cellular technology that transmits patients’ cardiac device diagnostic data to their clinicians from nearly any location in the world.
For more information: www.reveallinq.com