Medtronic CoreValve® System Obtains Early FDA Approval on Exceptional Clinical Performance
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`January 17, 2014
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`Self-Expanding Aortic Valve Serves Broad Spectrum of Potential Transcatheter Aortic Valve Replacement (TAVR) Patients Who Are Unable to
`Undergo Surgery
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`MINNEAPOLIS - Jan. 17, 2014 - Medtronic, Inc. (NYSE: MDT) today announced the U.S. 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.
`
`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 U.S. pivotal Trial, demonstrated even better survival
`and stroke performance. [i]
`
`"The low rates of stroke and valve leakage with the CoreValve System - two of the most concerning complications of valve replacement because they
`increase the risk of death and have a dramatic impact on quality of life - set a new standard for transcatheter valves," said Jeffrey J. Popma, M.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."
`
`In the U.S. 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.
`
`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. With the broadest size range
`available, the CoreValve System is suitable for patients with native valves of nearly all sizes. Its 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.
`
`"The FDA approval of CoreValve System is important for U.S. 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."  
`
`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 U.S.
`
`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.
`
`For more information about the CoreValve System, call 877-526-7890 or go to www.corevalve.com.
`
`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.
`
`Multimedia Release
`A multimedia version of this release, with links to graphics and additional background information can be found at: https://medtronicmediacap.gcs-
`web.com/medtronic-corevalver-system-receives-fda-approval-patients-high-risk-surgery
`
`ABOUT MEDTRONIC
`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 world.
`
`Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with
`
`Edwards Lifesciences Corporation, et al. Exhibit 1030, p. 1 of 2
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`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 Replacement with a Self-Expanding Transcatheter Heart Valve in Patients with Severe Aortic Stenosis
`
`Jeffrey J. Popma
`
`Contacts:
`Kathleen Janasz
`Public Relations
`+1-763-526-3637
`
`Jeff Warren
`Investor Relations
`+1-763-505-2696
`
`HUG#1753586
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` 
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`Edwards Lifesciences Corporation, et al. Exhibit 1030, p. 2 of 2
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