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www.fdanews.com/articles/162592-medtronic-kicks-off-global-launch-of-reveal-linq-insertable-cardiac-monitor

Medtronic Kicks Off Global Launch of Reveal LINQ Insertable Cardiac Monitor

February 20, 2014

Medtronic is launching its Reveal LINQ insertable cardiac monitor (ICM) in the U.S. and Europe after receiving both FDA 510(k) clearance and CE marking, the Minneapolis, Minn.-based devicemaker said Wednesday afternoon. The device is indicated for patients experiencing arrhythmia-associated dizziness, palpitations, syncope and chest pain, as well as for patients at risk of arrhythmia.

At one-third the size of a AAA battery and with 20 percent more data memory than the recently released Reveal XT, Reveal LINQ is the smallest implantable cardiac monitoring device in the world — more than 80 percent smaller than other ICMs, according to Medtronic. Company spokesman Joey Lomicky said it underscores Medtronic’s effort to make ICMs smaller, less invasive and more usable.

The device is inserted underneath the skin on the upper left side of the chest via an incision of less than 1 cm and can monitor a patient’s heart rhythms for up to three years. “If the patient gets this in and has arrhythmia, then [their physician] can prescribe a therapy and the monitor would come out. If they want to continue to have their heart monitored, usually you can find answers in that three-year window,” Lomicky told Device Daily Bulletin.

Unlike its predecessor, Reveal LINQ sends information on the patient’s heart rhythms to the MyCareLink patient monitoring tool. MyCareLink then transmits the data via a secure network to physicians, who can also request special alerts of cardiac events.

If and when symptoms occur, patients can press the heart-shaped button on the Reveal Patient Assistant and, by placing that device over the implant, record their heart activity. — Lena Freund

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