Early Patient Cases With Fortis Valve Presented at EuroPCR 2014
PARIS, FRANCE -- (Marketwired) -- 05/20/14 -- 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
"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
"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
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.
David K. Erickson
Press spacebar to pause and continue. Press esc to stop.