Medtronic Announces FDA Approval and U.S. Launch of Next Generation Pacemakers
November 20 2017 - 9:00AM
YASTEST
Azure(TM) with BlueSync(TM)
Technology Improves Device Longevity
and Provides Automatic, Wireless Remote Patient Monitoring
DUBLIN - November 20, 2017 -
Medtronic plc (NYSE: MDT) today announced U.S. Food and Drug
Administration (FDA) approval and U.S. commercial launch for its
portfolio of Azure(TM) pacemakers with BlueSync(TM)technology.
Available in both single chamber and dual chamber models, the Azure
XT MRI and Azure S MRI pacemakers offer improved longevity,
estimated at 13.7 years (dual chamber) or 27 percent longer than
its predecessor,1 so patients
likely need fewer device replacements. The new pacemakers also
allow patients to have MRI (magnetic resonance imaging) scans in
either 1.5 or 3 Tesla (T) machines.
Azure pacemakers feature Medtronic-exclusive
BlueSync technology, which enables automatic, secure wireless
remote monitoring via the Medtronic CareLink(TM)Network, providing
timely alerts of clinically relevant patient events that can be
reviewed by a clinician at any time. Security controls implemented
and validated on BlueSync enabled devices include access
restrictions to protect integrity of device functionality and
end-to-end encryption to protect patient data.
The Azure XT pacemaker features the Medtronic
Reactive ATP(TM) (atrial-based antitachycardia pacing) algorithm,
which was shown in the MINERVA Trial and real-world studies to slow
the progression of atrial fibrillation (AF) in patients with
implanted cardiac devices.2 Common among
patients with cardiac devices, AF impairs quality of life and
increases the risk of hospitalization, stroke and death.3
"With the approval of Azure, clinicians managing
patients with bradycardia now have pacemakers with improved
longevity, and better ability to detect and reduce atrial
fibrillation" said John Liddicoat, M.D., senior vice president,
Medtronic, and president of the Cardiac Rhythm and Heart Failure
division. "BlueSync technology with Azure also enables secure and
automatic wireless data transmission to clinicians. Remote
monitoring with automatic data transmissions can result in earlier
clinical decisions and improved patient monitoring compliance."
In tandem with the approval of these new
pacemakers, the Medtronic Percepta(TM) portfolio of quadripolar,
MR-conditional cardiac resynchronization therapy pacemakers
(CRT-Ps) also now includes BlueSync technology for secure, wireless
remote monitoring via the Medtronic CareLink Network.
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 84,000 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.
1 Orenga M.
Azure longevity Increase Compared to Advisa. September 2017.
Medtronic data on file.
2 Hudnall H.
Reactive Atrial-based Antitachycardia Pacing Therapy to Slow
Progression of Atrial Fibrillation. August 2017,
Medtronic data on file.
3 Chugh S,
Havmoeller R, Narayanan K, et al. Worldwide epidemiology of atrial
fibrillation: a global burden of disease 2010 study. Circulation.
2014; 129:837-847.
-end-
Contacts:
Ryan Mathre
Public Relations
+1-763-514-9625
Ryan Weispfenning
Investor Relations
+1-763-505-4626
This
announcement is distributed by Nasdaq Corporate Solutions on behalf
of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: Medtronic plc via Globenewswire
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