Medtronic Announces Approval and Launch of Reveal LINQ(TM) Insertable Cardiac Monitor in Japan
September 14 2016 - 9:00AM
Miniaturized
Device Now Available for Use in Patients with Unexplained Syncope
and Stroke
DUBLIN - Sept. 14, 2016
- Medtronic plc (NYSE: MDT) today 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.
About Medtronic
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.
Any forward-looking statements
are subject to risks and uncertainties such as those described in
Medtronic's periodic reports on file with the Securities and
Exchange Commission. Actual results may differ materially from
anticipated results.
-end-
______________________
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.
7 Schulz
UG, Rothwell PM. Differences in vascular risk factors
between etiological subtypes of ischemic stroke: importance of
population-based studies. Stroke.
2003;34:2050-2059.
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.
Contacts:
Ryan Mathre
Public Relations
+1-763-514-9625
Ryan Weispfenning
Investor Relations
+1-763-505-4626
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The issuer of this announcement warrants that they are solely
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information contained therein.
Source: Medtronic plc via Globenewswire
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