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";s:4:"text";s:21164:"At the completion of this educational activity, you will be better able to: Explain the risk factors for prosthesis-patient mismatch (PPM) and apply the best approach for each patient 0000008969 00000 n 0000044296 00000 n Searching for an experienced team that specializes in TAVR. Please leave any valuables at home or with a loved one/caregiver. 0000054618 00000 n [CDATA[ Forward-looking statements are based on estimates and assumptions made by management of the company and are believed to be reasonable, though they are inherently uncertain and difficult to predict. 0000006419 00000 n SAN FRANCISCO, Sept. 29, 2019 /PRNewswire/ -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced new data demonstrating early and sustained health status advantages for severe aortic stenosis (AS) patients at low surgical risk treated with the Edwards SAPIEN 3 valve. SAN FRANCISCO , Sept. 29, 2019 /PRNewswire/ -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced new data demonstrating early and sustained health status advantages for severe 0000018295 00000 n In the PARTNER 3 Trial, TAVR with the SAPIEN 3 system achieved superiority, with a 46 percent reduction in the event rate for the primary endpoint of the trial, which was a composite of all-cause mortality, all stroke and rehospitalization at one year. in Paris, France, on April 16, 2002, on a patient with severe aortic stenosis and cardiogenic shock as a treatment of last resort. 0000723558 00000 n 0000007130 00000 n 0000002869 00000 n phone: (800) 446-2617, Submit questions for the Investor Relations Department.Submit, Get news delivered straight to your inbox.Subscribe. 0000002982 00000 n 0000703427 00000 n See what happens during a TAVR procedure in this video animation for patients. Patient Success Story: Harolyn looks this good 60 minutes after TAVR, Join 300,000+ Patientsat Our Facebook Page Click here, HeartValveSurgery.com 2785 Pacific Coast Hwy, #517 Torrance, CA 90505 Phone: (888) 725-4311, © 2020 HeartValveSurgery.com. 0000006030 00000 n 0000002494 00000 n In 2019, TAVR received a FDA approval for low-risk patients. 0000018408 00000 n The entire procedure typically takes approximately 1–2 hours. h�b```b``������,� "��,;�1 ٬[E����&}�*����˰Ӂ���� �&���NO=]�u�1�n� ��[^�p8d��q���Mߘ�Hj�2P��Vwq7���-�bo5S�����x���{В3�l,��w��/$x0sȔ&��j��(H;0]�G��k����Ɗ�b4�-:���EB���었��^��d$�T���ɘp߱QIF=�A�Cr��F���Ǜ!�q�t&$2�����[�9���S� �)Mll"��2:�������h(B`���H. 0000703505 00000 n Learning Objectives. 0000001316 00000 n These factors are detailed in the company's filings with the Securities and Exchange Commission including its Annual Report on Form 10-K for the year ended December 31, 2018. 0000006497 00000 n 0000028547 00000 n 0000009302 00000 n 0000721317 00000 n document.write(new Date().getFullYear()) Transcatheter aortic valve replacement (TAVR) is a non-invasive treatment for severe aortic stenosis patients that does not require open-heart surgery or an incision to the patient’s chest. Our forward-looking statements speak only as of the date on which they are made, and we do not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date of the statement. "Taken together with the clinical outcomes of the PARTNER 3 Trial, these health status findings further support the use of TAVR in patients with severe aortic stenosis at low surgical risk," said Suzanne J. Baron, M.D., M.Sc., director of interventional cardiology research at Lahey Hospital and Medical Center. // endobj xref91 510000000016 00000 n Louisville, KY 40233-5000www.Computershare.com/investor 0000706175 00000 n When the treatment strategies were compared, TAVR patients improved more rapidly than surgery patients as demonstrated by a difference of 16.0 points between the groups in Kansas City Cardiomyopathy Questionnaire Overall Summary Scores (KCCQ-OS) at 1 month (p < 0.001). Edwards, Edwards Lifesciences, the stylized E logo, Edwards SAPIEN, Edwards SAPIEN 3, Edwards SAPIEN 3 Ultra, SAPIEN, SAPIEN 3, SAPIEN 3 Ultra, PARTNER, and PARTNER 3 are trademarks of Edwards Lifesciences Corporation. P.O. Mick Jagger, lead singer of the Rolling Stones, gets a non-invasive TAVR for aortic stenosis. This statement is made on behalf of Edwards Lifesciences Corporation and its subsidiaries. %PDF-1.4%���� As a result, many patients can now be considered for TAVR. Box 505000 "This study further demonstrates both early and late benefits of TAVR that are important to patients who lead active, productive lives.". 0000721434 00000 n While similar findings of early health status benefit with TAVR have been seen in prior studies of higher risk AS patients, this study also observed a sustained health status benefit of TAVR compared with SAVR at later time points of 6 months (2.6 points (p = 0.002)) and 1 year (1.8 points (p = 0.03)). 0000703973 00000 n View original content to download multimedia:http://www.prnewswire.com/news-releases/edwards-sapien-3-tavr-demonstrates-significant-health-status-improvements-for-low-risk-patients-300927310.html, Media, Heather Bukant, 949-250-5070, or Investors, Mark Wilterding, 949-250-6826 both of Edwards Lifesciences Corporation, investor_relations@edwards.com 0000080178 00000 n fax: (949) 250-2248, Computershare Investor Services 0000744112 00000 n 0000006669 00000 n 0000044362 00000 n The Heart Hospital performs its 1,000th TAVR procedure in Dallas, Texas. 0000703938 00000 n 0000721251 00000 n 0000043968 00000 n Keeping You Informed A Piedmont Atlanta Hospital patient representative will be present in the OR waiting room area. 0000725682 00000 n 0000007301 00000 n Watch the inspirational patient story of Jean Frank to learn more about TAVR. 0000009700 00000 n All rights reserved. 0000744503 00000 n All other trademarks are the property of their respective owners. Note: The above is a suggested flow for the patient screening process, however, the order in which screening // ]]> Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those expressed or implied by the forward-looking statements based on a number of factors including but not limited to unexpected outcomes after more expanded clinical experience, unexpected changes or delays related to product supply, potentials for unexpected regulatory or quality developments, competitive dynamics, or unexpected delays or changes in patient access, litigation or clinician acceptance. 0000002062 00000 n 0000006572 00000 n 0000064757 00000 n 0000018330 00000 n Transcatheter aortic valve replacement (TAVR) is a non-invasive treatment for severe aortic stenosis patients that does not require open-heart surgery or an incision to the patient’s chest.. Patient representative coverage is available from 7 a.m. to 7 p.m., Monday through Friday. Your heart team will determine whether you should have a mild sedative or general anesthesia. phone: (949) 250-2806 0000018178 00000 n Study results were presented as a late-breaking clinical trial at the 31st Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation, and simultaneously published online to the Journal of the American College of Cardiology. Sometimes a permanent pacemaker is needed after a TAVR procedure. TAVR was first performed as a proof-of-concept procedure by Cribier et al. The U.S. Food and Drug Administration approved the Edwards SAPIEN 3 and SAPIEN 3 Ultra valves for low-risk patients last month, based on data from the landmark PARTNER 3 Trial, and the launch is underway. A pacemaker is a device that uses electrical impulses to regulate your heart rhythm. This is a small wire through your vein in your leg into your heart that is most often taken out right after the procedure. The SAPIEN 3 TAVR system builds on Edwards' decades of experience in the development of tissue heart valves, and the proven benefits of the Edwards SAPIEN valves. Facts About TAVR. Furthermore, when mortality and the extent of quality of life improvement were evaluated together, the benefit of transfemoral TAVR with the SAPIEN 3 valve compared with surgery persisted through 1 year. be admitted to the hospital the day of your TAVR procedure. trailer<]/Prev 993885>>startxref0%%EOF 141 0 obj<>stream Breaking News: FDA Approves Low-Risk TAVR Devices by Medtronic & Edwards Lifesciences! 0000001951 00000 n 0000703888 00000 n "SAPIEN 3 TAVR is a proven technology with demonstrated clinical and health status superiority for these low-risk patients," said Larry Wood, Edwards' corporate vice president of transcatheter aortic valve replacement. Edwards Lifesciences, based in Irvine, Calif., is the global leader in patient-focused medical innovations for structural heart disease and critical care monitoring. 0000740431 00000 n 0000720924 00000 n A transcatheter aortic valve replacement procedure (TAVR) is less invasive than open heart surgery. Edwards Lifesciences Corporation. Every patient receives a temporary pacemaker during the TAVR procedure. This news release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. In 2019, TAVR received a FDA approval for low-risk patients. patient has been evaluated by two cardiac surgeons and meets the indication for TAVR Evaluate the aortic valvular complex using echocardio-graphy complex and peripheral vasculature using CT using catheterization. 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