Medtronic Launches App-Based Study to Better Understand Relationship Between Atrial Fibrillation Disease Burden and Impact on Patient Outcomes

DEFINE AFib Study Will Leverage Data from Medtronic Insertable Cardiac Monitors and Medtronic Discovery App™ with the Goal of Informing Atrial Fibrillation (AF) Management Strategies

Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced the initiation of the DEFINE AFib study, the company's first app-based research study. Using data collected from the LINQ family of insertable cardiac monitors (ICMs), the study aims to address unanswered questions around atrial fibrillation (AF) burden and its impact on patient outcomes, quality of life, and healthcare utilization. The first patients in the study were enrolled at Duke University Medical Center in Durham, N.C. by Jonathan Paul Piccini M.D., MHS, FHRS, director of Cardiac Electrophysiology and associate professor of medicine at Duke University School of Medicine, and at Florida Electrophysiology Associates in Atlantis, Fla. by Robert S. Fishel M.D., founder of the practice and director of Electrophysiology at JFK Medical Center.

DEFINE AFib will be conducted remotely through the new Medtronic Discovery App™ in coordination with U.S. sites that collectively will enroll approximately 5,000 patients. Study participants will include patients age 22 or older who have a history of AF, an iPhone device (iOS version 13 or higher), and one of the LINQ family of ICMs, among other criteria. The study will incorporate both device data and patient-reported data derived from scheduled patient surveys and the HealthKit — coupled with electronic health record information about medications and previous cardiac procedures — to provide comprehensive, actionable insights. Through a machine learning approach, aggregated study data will be leveraged to enable improved AF management in the future.

"When it comes to managing atrial fibrillation, there is not a 'one-size-fits-all' approach, and the hope is that DEFINE AFib may give us the tools to help personalize AF management based on a patient's individual health profile and physiology," said Dr. Piccini, who is also chair of the DEFINE AFib Steering Committee. "DEFINE AFib will harness the power of digital health to make fundamental discoveries about how we can manage atrial fibrillation better in each and every one of our patients."

Medtronic developed the app using the ResearchKit framework, given Apple's commitment to privacy and user-friendly experience. The app design leveraged insights from more than 100 hours of patient interviews to simplify and customize patient enrollment, data collection, and communication processes. Extensive app functionality will allow researchers to conduct DEFINE AFib and future large, integrated Medtronic studies remotely, with less site implementation burden.

"Traditional, in-person clinical studies are critically important to deepen our understanding of how to manage chronic conditions like AF but can place a lot of demands on the patients and physicians involved," said Julie Brewer , president of the Cardiovascular Diagnostics and Services business, which is part of the Cardiovascular Portfolio at Medtronic. "A fully app-based study design, with sophisticated data aggregation capabilities and remote monitoring using the LINQ family of ICMs, enables us to conduct DEFINE AFib without in-person patient enrollment or follow-up. This first-of-its-kind trial paves the way for future app-based studies at Medtronic."

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 of the highest quality 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 90,000 people worldwide, serving physicians, hospitals and patients in more than 150 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.

HealthKit and ResearchKit are trademarks of Apple Inc. registered in the U.S. and other countries. iOS is a registered trademark of Cisco in the U.S. and is used by Apple under license.

Contacts:




Lauren Mueller

Ryan Weispfenning

Public Relations

Investor Relations

+1-763-285-9053

+1-763-505-4626

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SOURCE Medtronic plc

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Medtronic advances Abbott CGM partnership with FDA submission of interoperable insulin pump

Medtronic advances Abbott CGM partnership with FDA submission of interoperable insulin pump

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced it has submitted 510(k) applications to the U.S. Food and Drug Administration (FDA) seeking clearance for an interoperable pump. FDA clearance of this pump would pave the way for system integration with a continuous glucose monitoring (CGM) sensor based on Abbott's most advanced CGM platform.

(PRNewsfoto/Medtronic plc)

The submissions included a 510(k) application for its MiniMed™ 780G pump as an alternate controller enabled (ACE) insulin pump and a separate 510(k) application for its SmartGuard™ algorithm as an interoperable automated glycemic controller (iAGC).

"We understand how meaningful these advancements are, and we're working with urgency to bring enhanced CGM options to our customers," said Que Dallara, EVP & president, Medtronic Diabetes. "This collaboration with Abbott marks an important step forward in providing innovative solutions and more choice for our customers."

This milestone follows the announcement last August that the companies will collaborate on an integrated system based on Abbott's most advanced CGM platform. Abbott will supply Medtronic with a CGM that will work exclusively with Medtronic smart dosing devices and software across both automated insulin delivery and smart multiple daily injections systems. These systems, including the Abbott CGM, will be sold exclusively by Medtronic.

More details will be shared when FDA clearance is secured.

About the Diabetes Business at Medtronic ( www.medtronicdiabetes.com )
Medtronic Diabetes is on a mission to alleviate the burden of diabetes by empowering individuals to live life on their terms, with the most advanced diabetes technology and always-on support when and how they need it. We've pioneered first-of-its-kind innovations for over 40 years and are committed to designing the future of diabetes management through next-generation sensors (CGM), intelligent dosing systems, and the power of data science and AI while always putting the customer experience at the forefront.

About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway , Ireland , is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic (NYSE: MDT), visit www.Medtronic.com and follow Medtronic on LinkedIn .

Any forward-looking statements, including, but not limited to, statements regarding the partnership between Medtronic and Abbott, strategic and other potential benefits of the partnership, Abbott's products and product candidates, and other statements about Medtronic managements' future expectations, beliefs, goals, plans or prospects, are subject to risks and uncertainties including, but not limited to, the ability to obtain regulatory approvals, and other risks and uncertainties such as those described in Medtronic's reports and other filings with the Securities and Exchange Commission. Actual results may differ materially from anticipated results. Medtronic cautions investors not to place considerable reliance on the forward-looking statements contained in this press release. These forward-looking statements speak only as of the date of this document, and Medtronic undertakes no obligation to update or revise any of these statements except to the extent required by law.

Contacts:
Janet Cho
Public Relations
+1-818-403-7028

Ryan Weispfenning
Investor Relations
+1-763-505-4626

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SOURCE Medtronic plc

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