Medtronic Announces FDA Approval and Launch of World's First App-Based Remote Monitoring System for Pacemakers
November 17 2015 - 09:00AM
MyCareLink
Smart(TM) Monitor
Conveniently Connects
Pacemaker Patients and Doctors
System Compatible
with Android(TM) and
Apple® Smartphones
and Tablets
DUBLIN - Nov. 17, 2015 -
Medtronic plc (NYSE: MDT) today announced U.S. Food and Drug
Administration (FDA) approval and U.S. commercial availability of
the MyCareLink Smart(TM) Monitor,
the world's first app-based remote monitoring system for patients
with implantable pacemakers. With the MyCareLink Smart Monitor,
patients with a Medtronic pacemaker can use their own smartphone or
tablet technology, with cellular or Wi-Fi service, to securely
transmit data from their pacemakers to their physicians, who can
then interpret the data to make treatment decisions.
"Remote monitoring of pacemakers and other cardiac
devices is now the standard of care, as studies have established
how it benefits patients - including faster diagnoses and increased
survival - as well as how it helps physicians manage their
pacemaker patients through increased efficiency and convenience,"
said George Crossley, III, M.D., associate professor of medicine
and electrophysiologist at Vanderbilt Heart and Vascular
Institution in Nashville, Tennessee. "Because the MyCareLink Smart
Monitor is integrated into existing mobile platforms like
smartphones and tablets, it is easy for patients to transmit data
from their pacemakers to their doctors via the technology that they
are using every day. This innovation will serve as the foundation
for future advances using smart technology to support cardiac
patients."
The MyCareLink Smart Monitor is comprised of a
handheld portable device reader, prescribed by a physician, and the
MyCareLink Smart mobile app, available for free on both
Android(TM) and
Apple® platforms.
When the MyCareLink Smart Monitor is connected to cellular or Wi-Fi
service, patients can initiate a transmission of pacemaker data by
securely uploading the information to the Medtronic
CareLink® Network, the
world's leading remote monitoring service for cardiac device
patients, currently being used by more than 1 million patients.
In addition to sending information from their
pacemakers to their physicians or clinics, patients using the
MyCareLink Smart Monitor can:
-
Confirm the date of their most recent
transmission of pacemaker information
-
Create a personalized profile on the MyCareLink
Connect Website to manage their pacemaker information and data
transmissions
-
Receive email or text reminders, confirmations
and notifications of their data transmissions
By connecting patients and physicians, remote
cardiac monitoring provides many clinical and economic benefits.
These include faster time to treatment if the physician detects a
problem with the pacemaker based on the transmitted
data;i
less time spent at a doctor's office or clinic for regular checks
of the pacemaker;ii,iiireduced
time spent in the hospital if the physician quickly detects and
treats a medical problem;iv,vand a
potential increase in patient survival rates.vi,vii,viii
"The use of smart technology continues to grow
among people of all ages, and especially among people over 65 which
is the age range of the majority of our pacemaker patients," said
Darrell Johnson, vice president and general manager of the
Connected Care business in the Cardiac and Vascular Group at
Medtronic. "As a leader in remote cardiac monitoring, Medtronic is
committed to providing cardiac patients with the latest technology
to improve their health and make their lives easier, while helping
to reduce the costs of healthcare. The MyCareLink Smart Monitor is
just the first of many innovative solutions we are developing that
leverage smart technology to increase patient engagement."
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 85,000 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-
Android is a
trademark of Google, Inc. Apple is a trademark of Apple Inc.,
registered in the U.S. and other countries.
i Crossley GH, et al. J Am
Coll Cardiol. 2011;57:1181-1189.
ii Cronin EM, et al. Heart Rhythm.
2012;9:1947-1951.
iii Varma N, et al. Am Heart J.
2007;154:1029-1034
iv Crossley GH, et al. J Am Coll Cardiol.
2011;57:1181-1189.
v Akar J, et al. LB03-03 Presented at HRS 2014.
vi Saxon LA, et al. Circulation.
2010;122:2359-2367.
vii Mittal S, et al. LB01-05 Presented at HRS 2014.
viii Akar J, et al. LB03-03 Presented at HRS 2014.
Contacts:
Ryan Mathre
Public Relations
+1-763-514-9625
Ryan Weispfenning
Investor Relations
+1-763-505-4626
This
announcement is distributed by NASDAQ OMX Corporate Solutions on
behalf of NASDAQ OMX 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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