FDA clearance & CE Mark of miniaturized Medtronic heart monitor leads to global launch
Medtronic, Inc. has announced U.S. Food and Drug Administration (FDA) 510(k) clearance, CE (Conformité Européenne) Mark, and the global launch of its Reveal LINQ Insertable Cardiac Monitor (ICM) System, 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. While 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 three years, with 20 percent more data memory than its larger predecessor, Reveal® XT.
In addition to its continuous and wireless monitoring capabilities, the system provides remote monitoring through the Carelink® Network. Through the Carelink Network, 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, and 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, M.D., professor and associate director of cardiac electrophysiology at the Northwestern University Feinberg School of Medicine in Chicago. "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."
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.
"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," said Pat Mackin, president of the Cardiac Rhythm Disease Management business and senior vice president at Medtronic. "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."
The Reveal LINQ system also includes the new MyCareLink ™ Patient Monitor, 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 healthcare systems more efficiently manage difficult patient populations," said Randy Lieberman, M.D., director of electrophysiology at Detroit Medical Center.