WASHINGTON, Nov. 1, 2016 /PRNewswire/ -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced new 5-year hemodynamic data from the PARTNER Trial demonstrating excellent durability of the first-generation Edwards SAPIEN transcatheter heart valve. This evaluation of 2,404 patients, encompassing 10,560 echoes and 6,493 patient years of follow-up, is the largest core lab based study of transcatheter heart valves to date. Results were presented during the late-breaking clinical trials session at the 28th Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation, in Washington, D.C.
"In the largest, most robust study of its kind, population hemodynamic trends show excellent durability of the SAPIEN transcatheter heart valve over five years, with virtually no structural valve deterioration," said Pamela Douglas, M.D., Ursula Geller professor of research in cardiovascular disease at Duke University and director of the Imaging Program at Duke Clinical Research Institute, who presented the data. "Similarly, large adverse hemodynamic echo findings in individual patients are rare in this protocol-driven database. Together, these data demonstrate excellent mid-term durability of THV, suggesting that the low 5-year survival observed in this cohort is not due to adverse hemodynamics."
Using three standard echocardiographic parameters, the study assessed hemodynamics (at 7 days, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years post-implant) and related the findings to clinical events of death and aortic valve re-intervention.
"We are very pleased with the scientifically rigorous 5-year outcomes data presented at TCT," said Larry L. Wood, Edwards' corporate vice president, transcatheter heart valves. "While this research is meaningful and important information for both clinicians and patients, we see this as the starting point for further evaluations, and our intention is to use the PARTNER and PARTNER II Trial data to generate additional longer-term evidence on durability for the SAPIEN family of heart valves."
The PARTNER Trial was the world's first prospective, randomized and controlled trial for transcatheter heart valves.
About Edwards Lifesciences
Edwards Lifesciences, based in Irvine, Calif., is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. 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. For more information, visit www.Edwards.com and follow us on Twitter @EdwardsLifesci.
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. These forward-looking statements include, but are not limited to, statements by Dr. Douglas and Mr. Wood and statements regarding expected durability and generation of longer-term evidence. 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. 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.
Forward-looking statements involve risks and uncertainties that could cause the roll-out and benefits of the technology 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 issues related to product supply, potentials for unexpected regulatory or quality developments. 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, 2015.
Edwards, Edwards Lifesciences, the stylized E logo, Edwards SAPIEN, PARTNER, PARTNER II, and SAPIEN are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.
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SOURCE Edwards Lifesciences Corporation