0000238979 00000 n 0000230560 00000 n 0000219228 00000 n 0000226887 00000 n 0000191238 00000 n 0000199166 00000 n 0000266716 00000 n 0000253692 00000 n 0000255056 00000 n 0000080413 00000 n 0000209181 00000 n 0000198256 00000 n 0000208117 00000 n 0000186673 00000 n 0000191084 00000 n 0000109998 00000 n 0000150407 00000 n 0000243182 00000 n The self-expanding Nitinol frame conforms and adapts to the annulus and provides consistent, outward radial force. 0000237598 00000 n 0000202953 00000 n 0000244007 00000 n 0000203252 00000 n 0000150345 00000 n 0000203103 00000 n 0000216316 00000 n startxref 0000227499 00000 n 0000223215 00000 n 0000190166 00000 n 0000248078 00000 n 0000225205 00000 n 0000251872 00000 n 0000207193 00000 n h޼V}LU���;nW��|�q i�r�(&�|�h$��A���O�?T�ݽ��ƞ5!W%B��@!�4�H�h�^�;��J� F�?Dc�Ƙ��8��Z���o�� ��M�f�̼��f~�� �p���({�Avl�=$���l�ӵ���S/���=�+ �r���ڽ-A�o���2%�Tzd�tF8Q�q��cU�C��_�ީ/����]K�M�+g���\:�E�{���Z�v�N. 0000213304 00000 n 0000197803 00000 n 0000184370 00000 n 0000240821 00000 n Copyright © 2019. 0000173923 00000 n 0000263996 00000 n 0000298377 00000 n 0000269752 00000 n DUBLIN, Aug. 21, 2020 (GLOBE NEWSWIRE) -- Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced the U.S. Food and Drug Administration (FDA) has approved revised commercial labeling for the Evolut™ TAVR platform that modified a precaution for the treatment of bicuspid severe aortic stenosis (AS) patients at a low risk of mortality during surgical aortic valve replacement. 0000226734 00000 n 0000266113 00000 n 0000175447 00000 n 0000299186 00000 n 0000033813 00000 n 0000208270 00000 n 0000032216 00000 n 0000238366 00000 n 0000217544 00000 n 0000225511 00000 n 0000229642 00000 n 0000259002 00000 n 0000030627 00000 n 0000211927 00000 n 0000033293 00000 n 0000298480 00000 n 0000242349 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. 0000203859 00000 n 0000222601 00000 n The approval comes just 4 days after researchers presented what the manufacturer says are the first clinical data on the valve at the American College of Cardiology (ACC) 2017 Scientific Session in Washington, DC. “Clinical outcomes generated to date through the TVT Registry and the Low Risk Bicuspid Trial have shown that the Evolut TAVR system achieves favorable early results for patients with bicuspid aortic valve disease,” said John Forrest, M.D., associate professor of medicine at The Yale University School of Medicine in New Haven, Conn. “The updated labeling is indicative of the progress that has been made to find minimally invasive treatment options for this particular group of patients with severe AS and should be part of the decision process made by heart teams evaluating patients with bicuspid aortic stenosis.”. 0000201284 00000 n 0000246411 00000 n 0000205072 00000 n 0000027311 00000 n 0000230255 00000 n 0000196177 00000 n 0000167681 00000 n 1034 0 obj <>stream 0000235304 00000 n 0000150150 00000 n 0000186212 00000 n 0000266565 00000 n Receive the the latest news, research, and presentations from major meetings right to your inbox. 0000080313 00000 n 0000227192 00000 n 0000260665 00000 n 0000264447 00000 n 0000250660 00000 n 0000172400 00000 n 0000241588 00000 n 0000276008 00000 n 0000223367 00000 n 0000170568 00000 n 0000033330 00000 n 0000221991 00000 n The self-expanding Nitinol frame conforms and adapts to the annulus and provides consistent, outward radial force. 0000233925 00000 n 0000247474 00000 n 0000223520 00000 n 0000240667 00000 n 0000252175 00000 n 0000173466 00000 n 0000249142 00000 n 0000212776 00000 n 0000236069 00000 n 0000235152 00000 n 0000261572 00000 n Meet the Evolut PRO System. 0000195303 00000 n 0000230408 00000 n Joey LomickyPublic Relations+1-763-526-2494, Ryan WeispfenningInvestor Relations+1-763-505-4626, Medtronic Evolut TAVR System Receives Updated U.S. Labeling Revising Precaution for Treatment of Low-Risk Patients with Bicuspid Aortic Stenosis. 0000264297 00000 n 0000297471 00000 n The Evolut TM R valve is built on a proven platform, which continues to demonstrate exceptional outcomes. 0000199317 00000 n 0000264748 00000 n 0000218157 00000 n 0000229183 00000 n 0000235917 00000 n 0000230104 00000 n 0000267323 00000 n 0000246563 00000 n 0000226275 00000 n 0000229950 00000 n The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together. 0000033417 00000 n 0000188333 00000 n 0000274939 00000 n 0000241742 00000 n 0000257486 00000 n 0000290129 00000 n 0000251719 00000 n 0000233463 00000 n 0000185290 00000 n 0000205829 00000 n 0000259758 00000 n 0000144464 00000 n 0000270968 00000 n

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