Edwards Sapien 3 transcatheter valve demonstrates positive patient outcomes at 30 days in European real-world experience
More than half of patients treated with conscious sedation
PARIS, Edwards Lifesciences Corporation, the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced that 30-day data from its European post-approval study of the Edwards SAPIEN 3 transcatheter aortic heart valve demonstrated positive patient outcomes, including the lowest reported mortality and stroke rates seen in the SOURCE family of registries. The new data were presented today at EuroPCR 2016 by Olaf Wendler, M.D., Ph.D., professor of cardiothoracic surgery at King’s College Hospital, London.
The SOURCE 3 Registry, a monitored and adjudicated prospective registry, is studying use of the low-profile Edwards SAPIEN 3 valve in a real-world commercial setting, treating patients with severe, symptomatic aortic stenosis. Patients treated via the transfemoral access route had a high survival rate of 98.1 percent at 30 days. Additionally, the study found a low stroke rate of 1.2 percent in transfemoral patients.
“The high survival and low stroke rates seen in the SOURCE 3 Registry with the SAPIEN 3 valve confirm the positive impact TAVR provides in the real-world setting,” Dr. Wendler said. “These results give us confidence that the excellent outcomes seen in early clinical trials using the SAPIEN 3 are reproducible by Heart Teams in routine practice.”
Data from the SOURCE 3 Registry documented the outcomes of 1,947 patients treated at 80 centers in Europe performing transcatheter aortic valve replacement (TAVR). Patients were enrolled in 10 countries between July 2014 and October 2015 and will be followed for five years. This represents the first large, multi-center report of SAPIEN 3 valve patient outcomes in a commercial setting, as well as the largest dataset of patients who were treated using conscious sedation with a singular valve platform (1,018 patients). Patients treated under conscious sedation are awake during the procedure and do not receive general anesthesia.
The Edwards SAPIEN 3 valve has been available in Europe since 2014. The Edwards SAPIEN family of valves are the most studied transcatheter heart valves in history and have been used in the treatment of more than 150,000 patients globally.
Wendler is a consultant to Edwards Lifesciences.
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, Dr. Wendler’s statements and statements regarding expected future product benefits and results. 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 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 longer term clinical experience with the product; or unanticipated quality, manufacturing or regulatory delays or issues. 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. These filings, along with important safety information about our products, may be found at edwards.com.
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