`
`Medtronic CoreValve(TM) Evolut(TM) R System First TAVI to Receive CE Mark for Intermediate Risk Aortic
`Stenosis Patients
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`August 1, 2016 10:00 AM CT
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`Next-Generation Recapturable Device is the First-of-its-Kind Approved in Europe to Treat Intermediate Risk Patients as an
`Alternative to Open-Heart Surgery
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`DUBLIN - August 1, 2016 - Medtronic plc (NYSE: MDT) today announced CE (Conformité Européenne) mark for the
`self-expanding, recapturable and repositionable CoreValve(TM) Evolut(TM) R System to treat aortic stenosis patients
`who are at intermediate risk for open-heart surgery as determined by a heart team. The Evolut R System is the first
`transcatheter aortic valve implantation (TAVI) therapy to obtain an expanded indication in Europe for this patient
`population.
`
`"The unique design of the self-expanding, supra-annular Evolut R System, coupled with its ability to be recaptured and
`repositioned for accurate valve placement, enables this device to be a viable treatment alternative for patients at
`intermediate surgical risk," said Prof. Eberhard Grube, M.D., director of the Structural Heart Program at University
`Hospital in Bonn, Germany. "The highly-anticipated intermediate risk indication marks an important milestone for the
`industry as we look to safely expand TAVI access to younger and less sick patient populations."
`
`The new intermediate risk indication approval for the CoreValve Evolut R System was based on positive clinical data from
`the Nordic Aortic Valve Intervention (NOTION) Trial and from a subset analysis from the CoreValve U.S. High Risk
`Pivotal Trial. Data from the NOTION trial showed that comparable clinical outcomes to surgery can be achieved by using
`CoreValve in patients who are good surgical candidates. Both datasets demonstrated excellent clinical performance for the
`CoreValve System with lower rates of all-cause mortality and major stroke compared to surgery. Additionally, data
`showed low incidences of procedural complications and superior hemodynamic performance (blood flow) compared to
`surgery.
`
`"This first-of-its-kind TAVI indication in Europe further demonstrates Medtronic's global leadership in the transcathether
`valve space and commitment to extending these benefits to new patient populations through rigorous clinical research and
`exceptional physician training and education," said Rhonda Robb, vice president and general manager of the heart valve
`therapies business, which is part of the Cardiac and Vascular Group at Medtronic. "We are continuing to support global
`heart teams with training and education on the Evolut R System to expand patient access to this minimally-invasive
`treatment option."
`
`The Evolut R valve is delivered through the EnVeo(TM) R Delivery Catheter System, which features an InLine(TM)
`Sheath that significantly reduces the profile to the lowest currently on the market (14 Fr equivalent, less than 1/5 inch). A
`smaller profile size provides a greater opportunity to treat patients with smaller vessels through the preferred
`transfemoral access route, and may minimize the risk of major vascular complications in some patients.
`
`The CoreValve Evolut R System and the EnVeo R Delivery Catheter System are now approved for use in patients at
`extreme, high and intermediate surgical risk in Europe and other countries that recognize the CE mark. The CoreValve
`Evolut R System was FDA-approved for commercial use in the United States in June 2015 for severe aortic stenosis
`patients who are at high or extreme risk for surgery.
`
`The CoreValve Evolut R System is not approved to treat intermediate risk aortic stenosis patients in the U.S.
`
`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
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`Edwards Lifesciences Corporation, et al., Exhibit 1056, p. 1 of 2
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`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-
`
`Contacts:
`Joey Lomicky
`Public Relations
`+1-763-526-2494
`
`Ryan Weispfenning
`Investor Relations
`+1-763-505-4626
`
`HUG#2032324
`
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`Edwards Lifesciences Corporation, et al., Exhibit 1056, p. 2 of 2
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