Edwards PASCAL Transcatheter System Receives CE Mark

PRNewswire 19-Feb-2019 4:15 PM

IRVINE, Calif., Feb. 19, 2019 /PRNewswire/ -- Edwards Lifesciences Corporation (NYSE:EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced the Edwards PASCAL transcatheter valve repair system has received CE Mark for the treatment of patients with mitral regurgitation.

"Mitral valve disease is complex, varied and prevalent, and patients are in significant need of multiple safe and effective therapies to treat debilitating symptoms that can lead to a high rate of mortality," said Bernard J. Zovighian, Edwards' corporate vice president, transcatheter mitral and tricuspid therapies. "The introduction of the PASCAL system to clinicians and patients in Europe provides a differentiated, minimally-invasive therapy to address the needs of patients with mitral regurgitation."

The PASCAL system is designed for effective reduction of mitral regurgitation while respecting the native anatomy. It features contoured, broad paddles to maximize coaptation of the mitral leaflets, and a central spacer that fills the regurgitant orifice area. The delivery system allows for independent leaflet capture and the ability to optimize leaflet position.

"The PASCAL system is uniquely designed for optimized valve leaflet capture and coaptation, and to help operators achieve their ultimate goal of safe and effective mitral regurgitation reduction for their patients," said Konstantinos Spargias, THV Director, Hygeia Hospital, Greece, and an investigator in the multi-national prospective CLASP Study.

The PASCAL system is one of multiple transcatheter repair or replacement therapies designed to address mitral and tricuspid valve diseases that are under development by Edwards. It represents the culmination of 20 years of innovation by Edwards to develop a novel, differentiated and advanced platform for patients in need.  The company is building upon a long history of knowledge, experience and commitment to advance transformative therapies and develop a robust body of clinical evidence.

The PASCAL system is not approved in the United States; the CLASP IID U.S. pivotal trial is currently enrolling patients with symptomatic primary mitral regurgitation.

Dr. Spargias 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, Mr. Zovighian's and Dr. Spargias' statements and statements regarding expected product benefits, and the timing, scope and outcomes of the product launch.  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 product introduction, unanticipated outcomes of longer term clinical experience with the product, or unanticipated manufacturing, legal, 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, 2018. These filings, along with important safety information about our products, may be found at edwards.com.

Edwards, Edwards Lifesciences, the stylized E logo and PASCAL are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.  This statement is made on behalf of Edwards Lifesciences Corporation and/or its subsidiaries.

View original content to download multimedia:http://www.prnewswire.com/news-releases/edwards-pascal-transcatheter-system-receives-ce-mark-300798264.html

SOURCE Edwards Lifesciences Corporation