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`Press Release
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`Medtronic CoreValve® System Obtains Early FDA Approval on Exceptional Clinical
`Performance
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`‘* Medtronic
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`Self-Expanding Aortic Valve Serves Broad Spectrum of Potential Transcatheter Aortic Valve
`Replacement (TA VR) Patients Who Are Unable to Undergo Surgery
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`MINNEAPOLIS - Jan. 17, 2014 - Medtronic, Inc. (NYSE: MDT) today announced the US. Food and
`Drug Administration (FDA) approval of the self-expanding transcatheter CoreValve® System for
`severe aortic stenosis patients who are too ill or frail to have their aortic valves replaced through
`traditional open-heart surgery. Untreated, these patients have a risk of dying approaching 50
`percent at one year.
`
`The FDA granted approval of the CoreValve device without an independent device advisory panel
`review after reviewing the clinical outcomes in the Extreme Risk Study of the CoreValve U.S. Pivotal
`Trial, which demonstrated that the CoreValve System is safe and effective with high rates of survival
`and some of the lowest rates of stroke and valve leakage reported.
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`The Extreme Risk Study met its primary endpoint of death or major stroke at one year with a rate of
`25.5 percent, which was 40.7 percent lower (p<0.0001) in patients treated with the CoreValve than
`was expected (based on a performance goal developed in partnership with the FDA). At one month,
`the rate of stroke was 2.4 percent, and it remained low over time with a one-year rate of 4.1 percent.
`Additionally, 75.6 percent of patients were alive at one-year. Contemporary results through the
`Continued Access Study, an extension of the US. pivotal Trial, demonstrated even better survival
`and stroke performance. [I]
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`img ItI an tinll‘iI t
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`Ii
`said Jeffrey J. Popma, llll D.
`director of Interventional Cardiology at the Beth Israel Deaconess Medical Center, Boston, and co—
`principal investigator of the Trial. "The CoreValve U. S. Pivotal Trial was rigorously designed and
`applied clinical best practices. The trial results have redefined optimal TAVR outcomes in the areas
`that matter most to physicians and their patients, and the results are especially remarkable given the
`complex medical conditions and extreme frailty of this population."
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`In the US. Pivotal Trial, the CoreValve System also achieved exceptional hemodynamics, or blood
`flow, post-implant with results similar to the gold standard, surgical valves. Additionally, valve
`leakage (known as paravalvular leak or PVL) rates were low and decreased over time as the self—
`expanding valve conformed to the shape of a patient‘s annulus - an improvement that has not been
`reported in other major TAVR studies.
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`The CoreValve System was developed to serve the needs of the broadest range of patients with
`severe aortic stenosis. The FDA approved the entire CoreValve platform including the CoreValve
`Evolut(TM) 23mm, and the CoreValve 26mm, 29mm and 31mm valves. V\fith the broadest size
`range available, the CoreValve System is suitable for patients with native valves of nearly all sizes.
`lts self-expanding nitinol frame enables physicians to deliver the device to the diseased valve in a
`controlled manner, allowing for accurate placement. All valve sizes are delivered via the smallest
`(18Fr, or 6mm) TAVR delivery system available, making it possible to treat patients with difficult or
`small vasculature.
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`"The FDA approval of CoreValve System is important for US. heart teams as the CoreValve System
`will serve the broadest spectrum of aortic stenosis patients who are unable to undergo surgery,"
`said John Liddicoat, M.D., senior vice president, Medtronic, and president of the Medtronic
`Structural Heart Business. "By leveraging Medtronic's history and expertise in bringing therapies to
`patients, we are supporting heart teams through training and education, imaging and patient
`evaluation programs that exemplify our safe and deliberate approach to patient access."
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`Since obtaining CE (Conformité Européenne) Mark in 2007, the CoreValve System has been
`supported by Medtronic's deep TAVR expertise obtained through more than 50,000 implants outside
`the US.
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`For the High Risk Study of the CoreValve U.S. Pivotal Trial, which is comparing the CoreValve
`System to traditional open heart surgery, the FDA determined it will conduct a separate review of
`the data.
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`For more information about the CoreValve System, call 877-526-7890 or go to www.corevalve.com.
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`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.
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`Multimedia Release
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`A multimedia version of this release, with links to graphics and additional background information
`can be found at: http://bitJy/1thnYP
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`ABOUT MEDTRONIC
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`Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical
`technology - alleviating pain, restoring health and extending life for millions of people around the
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`Any fonNard-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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`-end-
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`[i]As presented at Transcatheter Cardiovascular Therapeutics (TCT 2013 Conference, CORE
`VALVE EXTREME RISK: A Prospective Study of Transcatheter Aortic Valve
`NORRED EXHIBIT 2227 - Page 2
`Replacement with a Self-Expanding Transcatheter Heart Valve in Patients with
`Severe Aortic Stenosis
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`.QQDIQQLS;
`Kathleen Janasz
`Public Relations
`+1 —763—526—3637
`
`Jeff Warren
`Investor Relations
`+1-763—505—2696
`HUG# 1 753586
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`NORRED EXHIBIT 2227 - Page 3
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