SAN FRANCISCO, Oct. 14, 2015 /PRNewswire/ -- Edwards
Lifesciences Corporation (NYSE: EW), the global leader in the
science of heart valves and hemodynamic monitoring, today announced
that details on the 13 first-in-human compassionate use cases with
its FORMA transcatheter tricuspid repair system were presented at
the 27th Transcatheter Cardiovascular Therapeutics
(TCT), the annual scientific symposium of the Cardiovascular
Research Foundation. The results of the first seven cases
were also published online this week in the Journal of the
American College of Cardiology.
"Moderate-to-severe tricuspid regurgitation (TR) is present in
an estimated 1.6 million Americans1, yet isolated
tricuspid valve surgery is extremely rare. Severe TR is an
under-recognized and under-treated condition, and it is associated
with a poor prognosis," said Josep Rodes-Cabau, MD, Quebec Heart
& Lung Institute, Laval University. "We are
encouraged by our early experience with the FORMA system in which a
valuable finding was that patients had positive changes in their
symptoms and quality of life. We look forward to further
study to learn if an isolated tricuspid transcatheter treatment can
improve the prognosis for patients with severe
TR."
All 13 of the patients discussed at TCT presented with severe
functional TR and were determined to be high risk and deemed
unsuitable for surgery by a heart team. All had clinical
signs of heart failure. Twelve of the 13 patients had
successful implantation of the FORMA system. There were no deaths
and no major clinical complications reported in any of the 13
patients.
The investigators concluded from their early experience that
transcatheter reduction of functional TR appears safe and feasible
with the FORMA repair system and TR reduction was observed in all
successfully implanted patients, along with improvements in
peripheral edema and functional status. They noted that
longer-term follow up and larger studies are required to confirm
these preliminary results.
The FORMA system is designed to reduce tricuspid regurgitation
by occupying the regurgitant orifice area and providing a surface
for the coaptation of the valve's native leaflets. The device
consists of a foam-filled polymer balloon "spacer" and a rail that
is anchored at the right ventricular apex. Implantation is
performed via left axillary vein access. The FORMA system has been
designed to be fully retrievable during all stages of the
procedure, if needed, until sheath removal.
Clinical study planning is underway for an Early Feasibility
Study in the United States, as
well as a multi-center European and Canadian study. The FORMA
system is an investigational device and not for sale in any
country.
Rodes-Cabau is a consultant to Edwards Lifesciences.
1 Campelo-Parada F et al. First-in-man
Experience of a Novel Transcatheter Repair System for Treating
Severe Tricuspid Regurgitation, Journal of the American College of
Cardiology (2015), doi: 10.1016/j.jacc.2015.09.068.
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. Rodes-Cabau and statements regarding the
potential need for, and features, safety, and benefits of, the
FORMA system. 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
following longer term and expanded clinical experience and rigorous
clinical trials. 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, 2014. These filings, along
with important safety information about our products, may be found
at www.edwards.com.
Edwards, Edwards Lifesciences, the stylized E logo and FORMA are
trademarks of Edwards Lifesciences Corporation. All other
trademarks are the property of their respective owners.
Logo -
http://photos.prnewswire.com/prnh/20140714/126903
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/early-human-cases-with-edwards-forma-tricuspid-repair-system-presented-at-tct-300159632.html
SOURCE Edwards Lifesciences Corporation