IRVINE, Calif., April 30, 2018 /PRNewswire/ -- Edwards
Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical
care monitoring, today announced that it has received CE Mark for the Edwards Cardioband Tricuspid Valve Reconstruction System
for the treatment of tricuspid regurgitation. The Cardioband Tricuspid System is the first commercially available transcatheter
therapy for the treatment of tricuspid heart valve disease.
"Although open-heart surgical valve repair is practiced today, it has not been performed frequently for those suffering from
tricuspid regurgitation, despite evidence of increased mortality in these patients," said Prof. Georg
Nickenig, chief, Department of Cardiology, University Hospital, Bonn, Germany. "Now with
the European approval of the Cardioband Tricuspid System as the first transcatheter tricuspid therapy, patients can have access
to a minimally invasive treatment designed to reduce tricuspid regurgitation and improve their symptoms and quality of life."
The Cardioband Tricuspid System is delivered via a transfemoral approach and is designed to reduce tricuspid regurgitation
through annular reduction. It enables precise positioning to a patient's specific anatomy and real-time adjustment with
simultaneous confirmation of results. It is the same design and implant technique as is used for the Cardioband Mitral
System.
"We are very pleased to be developing the most comprehensive product portfolio to address both mitral and tricuspid valve
disease and to demonstrate continued progress on this robust pipeline of innovative transcatheter therapies for patients in
need," said Bernard Zovighian, corporate vice president, transcatheter mitral and tricuspid
therapies. "The clinical results of the TRI-REPAIR CE Mark study with the Cardioband Tricuspid System demonstrate the promise of
this treatment option for those with tricuspid regurgitation. We are committed to building a significant body of clinical
evidence, including the collection of real-world data, on this important new therapy for patients who have few or no other
treatment options."
Data on the Cardioband Tricuspid System will be presented in May at EuroPCR 2018. The Cardioband System is not approved
for commercial sale in the United States.
Edwards acquired the Cardioband System from Valtech Cardio in January 2017, and the receipt of
the CE Mark is one of the pre-specified milestones that prompts a distribution of cash and stock totaling approximately
$50 million to the former investors of Valtech
Cardio.
Prof. Nickenig has received compensation from Edwards for educational and training activities.
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, statements
by Prof. Nickenig and Mr. Zovighian, as well as statements regarding potential product benefits and releases of clinical data.
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, unanticipated outcomes
after longer term clinical experience, as well as unexpected regulatory, reimbursement, manufacturing, or quality-related
delays or issues. These and other additional 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, 2017. These
filings, along with important safety information about our products, may be found at www.edwards.com.
Edwards, Edwards Lifesciences, the stylized E logo, Cardioband, and Valtech are trademarks of Edwards Lifesciences Corporation
or its affiliates. All other trademarks are the property of their respective owners.
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SOURCE Edwards Lifesciences Corporation