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`Medtronic Expands TAVR Access to More Patients With Symptomatic, Severe Aortic Stenosis Upon Intermediate
`Risk FDA Approval
`
`July 10, 2017 10:35 AM CT
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`Self-Expanding CoreValve(TM) Evolut(TM)TAVR Platform with Excellent Procedural Safety and Proven Valve Performance
`Helps Address Needs of Intermediate-Risk Patients
`
`DUBLIN - July 10, 2017 - Medtronic plc (NYSE: MDT) today announced the expanded U.S. Food and Drug
`Administration (FDA) approval of the self-expanding CoreValve(TM) Evolut(TM) transcatheter aortic valve replacement
`(TAVR) platform to include patients with symptomatic severe aortic stenosis who are at an intermediate risk for
`open-heart surgery. With hemodynamic performance (a measure of blood flow efficiency) shown to be superior to surgical
`aortic valve replacement (SAVR), the CoreValve Evolut platform is designed to deliver excellent valve performance for
`these patients who are often considered to be more active than high- or extreme-risk patients previously indicated for the
`procedure.
`
`Patients who are at intermediate risk for open-heart surgery have a risk of mortality of >= 3 percent at 30 days following
`the procedure. The risk assessment is determined by a heart team (including an interventional cardiologist and cardiac
`surgeon), in combination with the Society of Thoracic Surgeons (STS) score and other factors, such as co-morbidities,
`frailty, prior surgical intervention and disabilities.
`
`"As evidenced by the landmark SURTAVI trial, the CoreValve Evolut platform is well-suited for the intermediate-risk
`patient population due to its supra-annular design for unsurpassed hemodynamics, low rates of mortality and disabling
`stroke, earlier improvement in quality of life, fast functional recovery times and short hospital stays," said Michael
`Reardon, M.D., professor of cardiothoracic surgery and Allison Family Distinguished Chair of Cardiovascular Research at
`Houston Methodist DeBakey Heart & Vascular Center. "It's important to consider that in the first 30 days, patients
`treated with TAVR showed functional improvements and lower rates of stroke than the surgical patients in the study."
`
`Recently unveiled at the 2017 American College of Cardiology meeting, the global SURTAVI trial evaluated
`intermediate-risk patients and compared 863 TAVR patients treated with the CoreValve and Evolut R Systems (STS: 4.4
`percent) to 794 surgical patients (STS: 4.5 percent). Against the strongest surgical performance (compared to predicted
`surgical risk of mortality) seen to date in a randomized trial, the CoreValve Evolut platform met its primary endpoint of
`non-inferiority compared to surgery in all-cause mortality or disabling stroke (12.6 percent for TAVR versus 14.0 percent
`for SAVR; posterior probability of non-inferiority >0.999). The CoreValve Evolut platform also demonstrated
`significantly better mean aortic valve gradients (7.8 mm Hg vs. 11.8 mm Hg; p<0.001) at two years. SAVR was associated
`with less aortic regurgitation, major vascular complications and need for permanent pacemaker implantation.
`
`"Patients at intermediate risk for open-heart surgery account for a large portion of the severe aortic stenosis population,"
`said Rhonda Robb, vice president and general manager of the Heart Valve Therapies business, a part of Medtronic's
`Cardiac and Vascular Group. "We are delighted to take the self-expanding CoreValve Evolut platform to more patients with
`aortic stenosis who can benefit from this therapy."
`
`The CoreValve Evolut platform consists of the CoreValve, CoreValve Evolut R and the recently FDA-approved CoreValve
`Evolut PRO systems, which are available for use in the United States with severe aortic stenosis patients at an
`intermediate surgical risk or greater. The CoreValve Evolut PRO System is currently not approved for commercial use
`outside of the United States.
`
`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 1057, 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 91,000 people worldwide, serving physicians, hospitals and patients in more than
`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
`
`Edwards Lifesciences Corporation, et al., Exhibit 1057, p. 2 of 2
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