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Insertable cardiac monitor receives FDA clearance, CE mark

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Medtronic announced that its Reveal LINQ insertable cardiac monitor has received both FDA 510(k) clearance and a CE Mark.

The device is indicated for patients who experience symptoms such as dizziness, palpitation, syncope and chest pain that may suggest cardiac arrhythmia, as well as for patients at increased risk for cardiac arrhythmia, according to a Medtronic press release.

At approximately 1 cc, the Reveal LINQ is the smallest implantable cardiac monitoring device available for patients and is more than 80% smaller than other insertable cardiac monitors, according to the release. The device is also smaller and offers 20% more data memory than its predecessor, the Reveal XT.

Rod Passman

Reveal LINQ has continuous and wireless monitoring capabilities and can provide remote monitoring through the Carelink Network, which can alert physicians if their patients experience cardiac events, according to the release.

The device is placed beneath the skin though an incision of <1 cm in the upper left side of the chest, according to the release. “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,” Rod Passman, MD, MSCE, professor and associate director of cardiac electrophysiology at the Northwestern University Feinberg School of Medicine, said in the release.