Medtronic Announces Global Launch of Reveal LINQ Insertable Cardiac Monitor

February 19, 2014—Medtronic, Inc. (Minneapolis, MN) announced US Food and Drug Administration 510(k) clearance, CE Mark approval, and the global launch of its Reveal LINQ insertable cardiac monitor (ICM) system, the smallest implantable cardiac monitoring device available for patients. 

The company stated in it’s press release that the Reveal LINQ ICM is approximately one-third the size of a AAA battery, making it more than 80% smaller than other ICMs. Although significantly smaller, the device is part of a powerful system that allows physicians to continuously and wirelessly monitor a patient’s heart for up to 3 years, with 20% more data memory than its larger predecessor, Reveal XT.  

According to the press release, in addition to its continuous and wireless monitoring capabilities, the system provides remote monitoring through Medtronic’s CareLink Network. Through this system, physicians can request notifications to alert them if their patients have had cardiac events. The Reveal LINQ ICM is indicated for patients who experience symptoms such as dizziness, palpitation, syncope (fainting), and chest pain that may suggest a cardiac arrhythmia, as well as for patients at increased risk for cardiac arrhythmias.

“The Reveal LINQ ICM monitor can help patients find answers to problems that may be heart-related without interrupting their lifestyle,” said Rod Passman, MD, Professor and Associate Director of Cardiac Electrophysiology at the Northwestern University Feinberg School of Medicine in Chicago, Illinois. “The simplified procedure and insertion tools make the device faster and easier for physicians to implant, which may expand access to more patients needing long-term monitoring.” 

The company explained that the device is placed via a minimally invasive procedure just beneath the skin through a small incision of < 1 cm in the upper left side of the chest. It is often nearly invisible to the naked eye once inserted. The Reveal LINQ ICM is MR-conditional, allowing patients to undergo magnetic resonance imaging in the future, if needed.

Additionally, the Reveal LINQ system also includes the new MyCareLink patient monitor, which 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. “This is a technology that is going to help us reach more patients at risk for cardiac arrhythmias and help health care systems more efficiently manage difficult patient populations,” said Randy Lieberman, MD, Director of Electrophysiology at Detroit Medical Center in Detroit, Michigan.