Edwards SAPIEN 3 Valve Demonstrates High Survival And Low Stroke Rate At 1 Year
SAN FRANCISCO, Oct. 15, 2015 /PRNewswire/ -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today announced that high-risk patients who received the advanced Edwards SAPIEN 3 transcatheter aortic valve via transfemoral delivery had a one-year survival rate of 89.3 percent, as well as low rates of stroke and paravalvular leak. The independently adjudicated data from The PARTNER II S3 Trial, which studied 583 high-risk and inoperable patients in the United States, were presented by Howard C. Herrmann, M.D., the John Winthrop Bryfogle Professor of Cardiovascular Diseases, and Director of Penn Medicine's Interventional Cardiology Program in the Perelman School of Medicine at the University of Pennsylvania, during the late-breaking clinical trials session at the 27th Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation.
Among the one-year outcomes reported in this large, rigorous U.S. FDA study, SAPIEN 3 transcatheter aortic valve replacement (TAVR) was associated with a very low overall disabling stroke rate of 2.4 percent, which is lower than this patient population's general risk of stroke.1,2
There were zero patients with severe paravalvular leak and only 2.7 percent with moderate paravalvular leak. Furthermore, for patients with mild or less paravalvular leak, there was no association with increased mortality. There was no evidence of clinical valve thrombosis or structural valve deterioration in these patients.
"These excellent results with the SAPIEN 3 valve support the use of TAVR as the preferred therapy for patients at high or greater risk for surgical aortic valve replacement," said Herrmann. "The combination of new design features of the SAPIEN 3 valve, procedural improvements, operator experience and improved patient selection have all contributed to strikingly low rates of one-year mortality, as well as other important adverse events, including stroke, in high-risk and inoperable patients with severe aortic stenosis."
The SAPIEN 3 study is a single-arm, non-randomized cohort of The PARTNER II Trial. The one-year analysis documented outcomes of the first 583 patients, whose average age was over 80, treated with the SAPIEN 3 valve at 29 centers nationwide and concluded January 2014. Access approaches included transfemoral (n=491) and transapical/transaortic (n=92), both high-risk and inoperable, as determined by the Heart Team.
The SAPIEN 3 valve was approved in Europe in January 2014 and in the U.S. in June 2015 for the treatment of high-risk patients with severe aortic stenosis.
Clinical Outcomes at 1 Year from The PARTNER II High-Risk/Inoperable Trial with the SAPIEN 3 Valve (As-Treated):
| Clinical Outcomes |
30 Days |
1 Year |
| All-cause mortality - % |
2.2 |
14.4 |
| Stroke: disabling - % |
0.9 |
2.4 |
All percents cited in the press release are Kaplan-Meier estimates.
Herrmann has received speaking honoraria from Edwards Lifesciences.
1 Mozaffarian D et al. Heart disease and stroke statistics - 2015 Update: A report from the American Heart Association. Circulation 2015;e29-e322.
2 Friberg L et al. Evaluation of risk stratification schemes for ischemia stroke and bleeding in 182678 patients with atrial fibrillation: the Swedish Atrial Fibrillation cohort study. European Heart Journal 2012;33, 1500-1510.
About Edwards Lifesciences
Edwards Lifesciences is the global leader in the science of heart valves and hemodynamic monitoring. Driven by a passion to help patients, the company partners with clinicians to develop innovative technologies in the areas of structural heart disease and critical care monitoring, enabling them to save and enhance lives. Additional company information can be found at www.edwards.com.
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. Herrmann and statements regarding patient follow-up, design features and expected product benefits and procedural outcomes of TAVR with the Edwards SAPIEN 3 valve. 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 actual 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 and longer term follow-up, unexpected product supply, regulatory or quality developments, and changes to trends in customer experience or patient follow-up. 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, 2014. These filings, along with important safety information about our products, may be found at www.edwards.com.
Edwards, Edwards Lifesciences, the stylized E logo, Edwards SAPIEN, Edwards SAPIEN 3, PARTNER, PARTNER II, SAPIEN and SAPIEN 3 are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.
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SOURCE Edwards Lifesciences Corporation
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