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0000176209 00000 n 0000264748 00000 n 0000224593 00000 n 0000240821 00000 n 0000182378 00000 n 0000237138 00000 n 0000080413 00000 n 0000265507 00000 n The revised commercial labeling includes recommendations heart teams should consider when assessing TAVR as a potential treatment option for bicuspid patients, including patients’ anatomical characteristics, age, long term durability, and the existing clinical data.
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0000233617 00000 n 0000293731 00000 n 0000166925 00000 n 0000237751 00000 n 0000290129 00000 n The Evolut TAVR platform – including the Evolut™ R, Evolut™ PRO and Evolut™ PRO+ TAVR Systems – is indicated for symptomatic severe AS patients across all risk categories (extreme, high, intermediate and low) in the U.S. 0000186519 00000 n 0000017446 00000 n 0000275245 00000 n 0000232393 00000 n
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0000212622 00000 n 0000171026 00000 n 0000028788 00000 n The revised labeling is supported by recent data from the Low Risk Bicuspid Study, which showed bicuspid patients implanted with Evolut TAVR had low rates of all-cause mortality or disabling stroke at 30 days (1.3%), a low rate of serious procedural complications, no annular ruptures or aortic dissections and no moderate/severe paravalvular leak. 0000181919 00000 n 0000232699 00000 n 0000263845 00000 n 0000203252 00000 n
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0000240051 00000 n 0000182225 00000 n 0000218616 00000 n “The increased adoption of the Evolut platform globally is partially attributed to the fact that it meets the needs of a broad variety of patients including those who have unique anatomical variations,” said Jeffrey Popma, M.D., chief medical officer and vice president, medical affairs for the Structural Heart business, which is part of the Cardiac and Vascular Group at Medtronic. 0000202804 00000 n
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0000241588 00000 n In this review, we highlight the evidence behind the use of TAVR, improvement in devi-ces over previous generations, clinical evidence behind the CoreValve Evolut PRO system, and the future of TAVR. 0000034673 00000 n 0000196891 00000 n 0000235304 00000 n 0000209181 00000 n 0000235611 00000 n The latest iteration of the self-expandable valve is Medtronic’s reposi-tionable valve known as the Evolut PRO system.
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The valve is made from strong and pliable porcine pericardial tissue, making it durable and allowing a low-profile delivery. 0000184524 00000 n
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0000262784 00000 n 0000272345 00000 n 0000146868 00000 n 0000270662 00000 n 0000273717 00000 n 0000027995 00000 n The self-expanding Nitinol frame conforms and adapts to the annulus and provides consistent, outward radial force. 0000218005 00000 n 0000245501 00000 n 0000143207 00000 n 0000256575 00000 n 0000274939 00000 n 0000181766 00000 n
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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. 0000029673 00000 n 0000210542 00000 n 0000171790 00000 n 0000238519 00000 n
0000234232 00000 n Medtronic receives FDA approval for CoreValve Evolut Pro transcatheter valve with advanced sealing. 0000270056 00000 n 0000189095 00000 n
0000028125 00000 n 0000295337 00000 n
0000174990 00000 n 0000270511 00000 n Actual results may differ materially from anticipated results. 0000292140 00000 n 0000251567 00000 n 0000240667 00000 n
0000274480 00000 n 0000233157 00000 n 0000247474 00000 n 0000252477 00000 n Medtronic employs more than 90,000 people worldwide, serving physicians, hospitals and patients in more than 150 countries.
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