Feb. 19--Medtronic Inc. on Wednesday announced U.S. Food and Drug Administration approval and CE Mark for the global launch of its miniature, wireless cardiac monitoring device, called the Reveal Linq ICM.
The tiny monitor is about one-third the size of a AAA battery in volume, 80 percent smaller than other such devices. It is placed just beneath the skin through a small incision on the upper left side of the chest and allows physicians to continuously and wirelessly monitor a patient's heart for up to three years. It has 20 percent more data capacity than its larger predecessor, the Reveal XT, Medtronic said.
The system provides remote monitoring through Medtronic's Carelink network. The system can alert doctors if their patients have had cardiac events. The Reveal Linq is approved for patients who experience symptoms such as dizziness, heart palpitation, fainting and chest pain, as well as for patients considered at increased risk for abnormal heart rhythm.
"The Reveal Linq ICM monitor can help patients find answers to problems that may be heart-related without interrupting their lifestyle," said Dr. Rod Passman, 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."
Pat Mackin, president of Medtronic's cardiac rhythm disease management business, said the miniaturized system is the result of many years of work by 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 said.
James Walsh -- 612-673-7428
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