Press Release

Medtronic Announces FDA Approval and Launch of World's First App-Based Remote Monitoring System for Pacemakers

Medtronic plc

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.

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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


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