Edwards Lifesciences Announces First Human Implants With Mitral Transcatheter Valve System
March 06 2014 - 9:00AM
Marketwired
Edwards Lifesciences Announces First Human Implants With Mitral
Transcatheter Valve System
IRVINE, CA--(Marketwired - Mar 6, 2014) - Edwards Lifesciences
Corporation (NYSE: EW), the global leader in the science of heart
valves and hemodynamic monitoring, today announced the successful
completion of the first three human implants of its FORTIS mitral
transcatheter heart valve, which were performed in February and
March by the Heart Team at St. Thomas' Hospital in London.
"These first patients had severe mitral valve disease and many
risk factors that prevented them from undergoing
surgery. After careful evaluation and close consultation with
the patients and their families, we determined that this therapy
could potentially extend and improve their lives. At this
early stage, we are very pleased with the initial recoveries of
these patients," said Vinayak "Vinnie" Bapat, FRCS CTh, consultant
cardiothoracic surgeon, St. Thomas' Hospital in London. "We're
very proud to play a role in advancing the investigation of this
developing therapy, which has the potential to fulfill an unmet
need among many patients." Bapat and the hospital's Heart Team
-- also led by Martyn Thomas, MD, FRCP, clinical director of
cardiovascular services, and Jane Hancock, MD, PhD, MRCP,
consultant cardiologist specializing in imaging -- are experienced
in less invasive valve procedures, including transcatheter aortic
valve replacement (TAVR).
The FORTIS transcatheter mitral valve features Edwards' most
advanced, treated bovine pericardial tissue. It features a
cloth-covered self-expanding frame designed to minimize
paravalvular leak, and a unique anatomical anchoring
system. This series of implants is being performed via a
transapical approach to allow direct surgical access to the mitral
valve complex.
"We believe mitral valve disease is undertreated worldwide, and
there is a particular need among patients who are too high risk to
benefit from traditional surgical options," said Michael A.
Mussallem, Edwards' chairman and CEO. "We'd like to thank the
Heart Team at St. Thomas' Hospital for their dedication to
providing outstanding patient care to these patients who faced
dismal prognoses and otherwise would have gone untreated. This
early experience provides a very important opportunity for learning
in this challenging anatomy. Although durable success will not
be known without significantly more experience and longer term
follow up, we are excited about this potential opportunity that we
believe may be very meaningful for patients."
Edwards expects these cases to be reviewed in the normal course
at future medical meetings. The company's transcatheter mitral
valve, which utilizes a transapical approach that a surgeon
performs through a small incision in the ribs, 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. Bapat and Mr. Mussallem, and the potential
timing and outcomes of the early clinical experiences with the
mitral transcatheter valve, and any potential benefits the valve
could provide. 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.
Media Contact: Sarah Huoh 949-250-5070 Investor Contact: David
K. Erickson 949-250-6826
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