Reveal Linq insertable cardiac monitor receives FDA clearance and CE mark

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Medtronic has announced US Food and Drug Administration (FDA) 510(k) clearance, CE mark, and the global launch of its Reveal Linq insertable cardiac monitor system, the smallest implantable cardiac monitoring device available for patients.

According to a press release, the Reveal Linq insertable cardiac monitor is approximately one-third the size of a AAA battery (~1 cc), making it more than 80% smaller than other insertable cardiac monitors. 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% 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, where physicians can request notifications to alert them if their patients have had cardiac events. The Reveal Linq insertable cardiac monitor 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.

“The Reveal Linq insertable cardiac monitor can help patients find answers to problems that may be heart-related without interrupting their lifestyle,” said Rod Passman, professor and associate director of cardiac electrophysiology at the Northwestern University Feinberg School of Medicine in Chicago, USA. “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 1cm in the upper left side of the chest, the Reveal Linq insertable cardiac monitor 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 insertable cardiac monitor is MR-Conditional, allowing patients to undergo magnetic resonance imaging (MRI) if needed.

The 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.

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