Early Patient Cases With Fortis Valve Presented at EuroPCR 2014
May 20 2014 - 8:10AM
Marketwired
Early Patient Cases With Fortis Valve Presented at EuroPCR 2014
PARIS, FRANCE--(Marketwired - May 20, 2014) - Edwards
Lifesciences Corporation (NYSE: EW), the global leader in the
science of heart valves and hemodynamic monitoring, today announced
that details about the first-in-human experience with Edwards'
FORTIS mitral transcatheter heart valve were presented at EuroPCR
2014 during the congress' late-breaking session on transcatheter
mitral therapies.
Vinayak "Vinnie" Bapat, FRCS CTh, consultant cardiothoracic
surgeon, St. Thomas' Hospital in London, and Martyn Thomas, MD,
FRCP, clinical director of cardiovascular services, St. Thomas'
Hospital, reviewed the first patient cases performed at their
hospital and Inselspital in Bern, Switzerland.
All of these patients had severe mitral regurgitation, marked
breathlessness, suffered from multiple co-morbidities and were not
candidates for surgical mitral valve intervention. Their medical
teams were granted access to the FORTIS device on
humanitarian/compassionate grounds. It was reported that, of the
first four cases with the FORTIS valve, three patients passed away
between days 4 and 76 post-procedure. One patient continued to be
followed at 76 days. A fifth patient was treated at St. Michael's
Hospital in Toronto, Canada, last week, and the patient is
recovering. Additional details about that case were not available
for the presentation. The physicians concluded that ongoing work
will establish optimal patient selection, procedural steps and
post-operative management.
"Clinicians know there are many patients suffering from mitral
valve disease who are too high risk to benefit from traditional
surgical options. Although these early patient outcomes have been
disappointing, we demonstrated that this valve can be successfully
implanted and functions as intended," said Dr. Thomas. "The mitral
valve and the mitral patient are complex. This journey is going to
be difficult, but I believe that this therapy should be pursued and
will lead to improved patient care." Dr. Thomas is a paid
consultant to Edwards.
"We are grateful for the Heart Teams that guided the
first-in-human implants with compassion and deep clinical
experience. Similar to the early days with transcatheter aortic
valves, we know developing transformational therapies is
challenging," said Michael A. Mussallem, Edwards' chairman and CEO.
"We are confident that our commitment to addressing the unmet needs
of patients will lead to transcatheter mitral valve replacement
becoming a meaningful therapy."
The FORTIS valve is not for sale in any country.
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 made by Dr.
Thomas and Mr. Mussallem, and statements about the potential for
improvements to the procedure, and the potential benefits of mitral
transcatheter valve therapy. 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 results of the
clinical experience after more procedures are completed or after
longer-term follow up, delays in the clinical trials or product
development efforts, or unanticipated decisions by regulatory
authorities. 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, 2013.
Edwards, Edwards Lifesciences, the stylized E logo and FORTIS
are trademarks of Edwards Lifesciences Corporation. All other
trademarks are the property of their respective owners.
Media Contact: Sarah Huoh 949-250-5070
Investor Contact: David K. Erickson 949-250-6826
Edwards Lifesciences (NYSE:EW)
Historical Stock Chart
From Mar 2024 to Apr 2024
Edwards Lifesciences (NYSE:EW)
Historical Stock Chart
From Apr 2023 to Apr 2024