Medtronic's (MDT) Reveal LINQ ICM Approved in Japan; Device Launched

September 14, 2016 9:03 AM EDT

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Medtronic plc (NYSE: MDT) announced it has received Ministry of Health, Labor and Welfare (MHLW) approval of the Reveal LINQ Insertable Cardiac Monitor (ICM) System in Japan. In addition, MHLW has granted reimbursement approval for Reveal LINQ as a result of work with the Japanese regulatory body. The device will be available in Japan beginning this month.

The Reveal LINQ ICM System is the smallest insertable cardiac monitoring device available (~1 cc, or one-third the size of an AAA battery); it is designed to help physicians quickly and accurately diagnose irregular heartbeats. 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 inserted using a minimally invasive procedure; its presence is often nearly undetectable to the naked eye once the incision has healed.

In Japan, the Reveal LINQ ICM will be used by physicians in the diagnosis of unexplained syncope (unexplained fainting) and cryptogenic stroke (stroke of unknown cause). Approximately 200,000 Japanese patients each year suffer from episodes of syncope, and 20 to 30 percent of these cases are diagnosed as unexplained.1 In addition, 243,000 ischemic strokes are estimated to occur annually in Japan (the most common type of stroke, caused by an obstruction denying blood to part of the brain)2 and 20 to 40 percent are cryptogenic, as reported by modern stroke registries and databases.3-9

"Medtronic is the pioneer in the miniaturization of medical devices that improve the overall experience for patients," said Nina Goodheart, vice president and general manager of the Diagnostics and Monitoring business at Medtronic. "We are pleased that through our collaboration with MHLW, we can now offer this minimally invasive technology for Japanese patients with syncope and cryptogenic stroke."

The Reveal LINQ ICM automatically and continuously detects and records abnormal heart rhythms for up to three years and is MR-Conditional, allowing patients to undergo magnetic resonance imaging (MRI), if needed. The device communicates wirelessly with a patient bedside monitor that uploads device data to the Medtronic CareLink® network.

In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world.

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