Edwards Receives FDA Approval For Expanded Indication Study Of SAPIEN 3 Valve
IRVINE, Calif., Jan. 15, 2016 — Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced U.S. Food and Drug Administration approval for an expanded indication study of its most advanced transcatheter aortic heart valve, the Edwards SAPIEN 3 valve. The investigational device exemption (IDE) study will enroll elderly patients with severe, symptomatic aortic stenosis (AS) who have been determined by a heart team to be at low risk for mortality if they were to undergo surgical aortic valve replacement.
Patients enrolled in the new PARTNER III Trial will be randomized to receive either the SAPIEN 3 valve or open surgical valve replacement. To be eligible for the trial, patients must be at least 65 years old, exhibit symptoms of severe AS and be determined by a heart team to have a surgical risk score of less than 4 percent per the Society of Thoracic Surgeons adult cardiac surgery risk calculator. The trial is a non-inferiority study with a one-year composite endpoint that includes death, stroke and rehospitalization. Enrollment of approximately 1,300 patients at up to 50 sites is expected to begin during the second quarter. The trial will also include a 400-patient sub-study using advanced imaging to evaluate leaflet motion in tissue heart valves.
“If this trial is successful, it will allow heart teams to choose a treatment approach that is best suited to every patient’s individual need. We are pleased to begin this important study of the SAPIEN 3 transcatheter valve to evaluate its safety and effectiveness in a broader group of elderly patients suffering from this deadly disease,” said Larry L. Wood, Edwards’ corporate vice president, transcatheter heart valves.
The SAPIEN 3 valve was approved in the United States in 2015 for the treatment of high-risk patients suffering from severe, symptomatic AS.
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 at @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, Mr. Wood’s statements and statements regarding expected timing, scope and outcomes of the clinical trial. 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 delays or changes in the clinical trial, unanticipated outcomes of the trial or longer term clinical experience with the product, or unanticipated quality 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, 2014. These filings, along with important safety information about our products, may be found at edwards.com.
Edwards, Edwards Lifesciences, the stylized E logo, Edwards SAPIEN, Edwards SAPIEN 3, PARTNER, SAPIEN and SAPIEN 3 are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.
SOURCE: Edwards Lifesciences