Study allegory shows after-effects of about 2,000 intermediate-risk patients at added than 450 U.S. centers
PARIS, May 22, 2018 /PRNewswire/ — Edwards Lifesciences Corporation (EW), the all-around baton in patient-focused innovations for structural affection ache and analytical affliction monitoring, today appear 30-day abstracts demonstrating that assay with the Edwards SAPIEN 3 valve in added than 450 bartering centers about the U.S. appearance consistently absolute accommodating outcomes. The data, involving about 2,000 severe, appropriate aortic binding patients at intermediate-risk of open-heart surgery, approved bendability with those after-effects accomplished in beforehand controlled analytic trials in a bound cardinal of hospitals.
Edwards Lifesciences logo. (PRNewsFoto/Edwards Lifesciences Corporation)
“We are actual admiring that, as the SAPIEN 3 valve assay was alien and activated by a broader cardinal of U.S. clinicians in a real-world environment, the accomplished accommodating outcomes appear from beforehand analytic trials were preserved,” said Larry L. Wood, Edwards’ accumulated carnality president, transcatheter affection valves. “Even as added hospitals offered transcatheter aortic valve backup with the SAPIEN 3 valve, the action was generalizable and effective. These anthology abstracts are an important adumbration that, affective from a anxiously controlled ambiance of a analytic trial, to connected admission and again to a bartering environment, absolute accommodating after-effects can be maintained back hospitals action broader admission to patients in need.”
The propensity-matched assay comparing real-world abstracts calm from the Society of Thoracic Surgeons and American College of Cardiology (STS/ACC) Transcatheter Valve Assay (TVT) Anthology with outcomes of patients enrolled in the PARTNER II studies of the SAPIEN 3 valve was presented today during the EuroPCR 2018 late-breaking analytic trials hotline affair by E. Murat Tuzcu, M.D., arch bookish administrator and the arch of cardiovascular anesthetic at the Affection & Vascular Institute at Cleveland Clinic Abu Dhabi.
“These abstracts comparing real-world outcomes with analytic abstraction after-effects in intermediate-risk patients advised with the Edwards SAPIEN 3 transcatheter affection valve approved analogously absolute outcomes including aerial adaptation ante and low ante of stroke,” Tuzcu said.
Outcomes in a absolute of 1,956 intermediate-risk patients in the STS/ACC TVT Anthology were compared with those of 652 intermediate-risk patients enrolled in the PARTNER II S3i abstraction and 652 patients enrolled in the SAPIEN 3 intermediate-risk connected admission affairs (S3iCAP) at 30 days.
All patients were advised via the transfemoral admission route. Important analytic measures from the assay are presented in the table below.
Clinical Outcomes at 30 Canicule (As-Treated)
S3i (N = 652)
S3iCAP (N = 652)
TVT Anthology IR (N = 1,956)
All-Cause Mortality %
All Achievement %
In accession to the accomplished adaptation and achievement rates, the post-approval abstracts from the TVT Anthology approved a low amount of abstinent to astringent paravalvular leak, as able-bodied as a two-day boilerplate breadth of stay.
The Edwards SAPIEN 3 valve has been accessible in Europe back 2014 and in the United States back 2015. In 2016, both European and U.S. regulators broadcast the approval to accommodate intermediate-risk patients. The SAPIEN 3 valve builds on Edwards’ decades of acquaintance in the development of tissue affection valves, and the accurate allowances of the Edwards SAPIEN valves.
About Edwards LifesciencesEdwards Lifesciences, based in Irvine, Calif., is the all-around baton in patient-focused medical innovations for structural affection disease, as able-bodied as analytical affliction and surgical monitoring. Driven by a affection to advice patients, the aggregation collaborates with the world’s arch clinicians and advisers to abode unmet healthcare needs, alive to advance accommodating outcomes and enhance lives. For added information, appointment www.Edwards.com and chase us on Twitter @EdwardsLifesci.
This account absolution includes advanced statements aural the acceptation of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These advanced statements include, but are not bound to, Mr. Wood and Dr. Tuzcu’s statements and statements apropos accepted artefact benefits. Advanced statements are based on estimates and assumptions fabricated by administration of the aggregation and are believed to be reasonable, admitting they are inherently ambiguous and difficult to predict. Our advanced statements allege alone as of the date on which they are fabricated and we do not undertake any obligation to amend any advanced account to reflect contest or affairs afterwards the date of the statement.
Forward-looking statements absorb risks and uncertainties that could account after-effects to alter materially from those bidding or adumbrated by the advanced statements based on a cardinal of factors, including but not bound to, abrupt outcomes afterwards best appellation analytic acquaintance with the product; or hasty quality, accomplishment or authoritative delays or issues. These factors are abundant in the company’s filings with the Securities and Exchange Commission including its Annual Report on Form 10-K for the year concluded December 31, 2017. These filings, forth with important assurance advice about our products, may be begin at edwards.com.
Edwards, Edwards Lifesciences, the august E logo, Edwards SAPIEN, Edwards SAPIEN 3, PARTNER, PARTNER II, SAPIEN, and SAPIEN 3 are trademarks of Edwards Lifesciences Corporation. All added trademarks are the acreage of their corresponding owners.
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