Medtronic plc 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.
Medtronic plc (www.medtronic.com ), headquartered in Dublin, Ireland, is among the world's largest medical technology, services and solutions companies – alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 88,000 people worldwide, serving physicians, hospitals and patients in approximately 160 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.
1 Japanese Guideline of Syncope 2012
2 Japanese Stroke Database 2015
3 Heart Disease and Stroke Statistics 2015 Update Circulation. 2015; 131:e29-e322 Published online before print December 17, 2014, doi: 10.1161/CIR.0000000000000152
4 Sacco RL, Ellenberg JH, Mohr JP, et al. Infarcts of undetermined cause: the NINCDS Stroke Data Bank. Ann Neurol. 1989;25:382-390.
5 Petty GW, Brown RD, Jr., Whisnant JP, et al. Ischemic stroke subtypes: a population-based study of incidence and risk factors. Stroke. 1999;30:2513-2516.
6 Kolominsky-Rabas PL, Weber M, Gefeller O, et al. Epidemiology of ischemic stroke subtypes according to TOAST criteria: incidence, recurrence and long-term survival in ischemic stroke subtypes: a population-based study. Stroke. 2001;32:2735-2740.
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8 Schneider AT, Kissela B, Woo D, et al. Ischemic stroke subtypes: a population-based study of incidence rates among blacks and whites. Stroke. 2004;35:1552-1556.
9 Lee BI, Nam HS, Heo JH, et al. Yonsei Stroke Registry. Analysis of 1,000 patients with acute cerebral infarctions. Cerebrovasc Dis. 2001; 12:145-151.