Five-Year Data Show Excellent Outcomes for Female and Small Annulus Patients With Edwards TAVR
05 Junio 2024 - 10:45AM
Business Wire
Edwards Lifesciences (NYSE: EW) today announced the results from
an analysis of data from the PARTNER Trials examining outcomes of
transcatheter aortic valve replacement (TAVR) patients with a small
annulus. Through five-year follow up of more than 1,300 low and
intermediate risk SAPIEN 3 valve patients there were excellent
clinical outcomes and valve durability irrespective of the
patient’s annulus size or sex. These data were presented during the
late-breaking clinical sessions at New York Valves 2024: The
Structural Heart Summit.
As part of this analysis, contemporary patient data with
long-term follow up from the PARTNER 3 randomized controlled trial
and PARTNER 2 S3i Trial were examined to determine if higher 30-day
mean gradients and rates of prothesis-patient mismatch (PPM)
translated to poorer long-term outcomes of death, disabling stroke
or heart failure related hospitalization. The analysis revealed no
association between clinical outcomes or valve durability and
severe PPM or higher mean gradients (i.e., >20 mmHg.) Overall,
this cohort of patients had extremely low rates of reintervention
and high survival out to five years. As previously presented, the
PARTNER 3 Trial demonstrated the highest reported survival rate in
low-risk patients seen in any pivotal trial.
“This important dataset highlights the risk of relying on a
singular hemodynamic parameter such as mean gradient as a surrogate
for valve dysfunction,” said Rebecca Hahn, MD, Professor of
Medicine at Columbia University Irving Medical Center, Chief
Scientific Officer of the Echo Core Lab at the Cardiovascular
Research Foundation and Director of Interventional Echocardiography
at the Columbia Structural Heart & Valve Center, speaking for
the PARTNER Trial investigators. “When selecting the best treatment
option, we must evaluate measures that matter to patients such as
death, disabling stroke, quality of life and reintervention. This
five-year follow up of low and intermediate risk patients
demonstrated no association of a mean gradient greater than 20 mmHg
or prosthesis-patient mismatch with these key outcomes for the
Edwards SAPIEN 3 platform. These are important findings for
clinicians in determining the best treatment for patients.”
“The PARTNER series of robust pivotal trials, all of which
included FDA oversight, rigorously followed more than 12,000
patients treated with Edwards SAPIEN valves rendering them
excellent data from which to examine the totality of factors that
contribute to valve durability and performance,” said Larry Wood,
Edwards’ corporate vice president and group president,
transcatheter aortic valve replacement and surgical structural
heart. “These data are reassuring for patients and clinicians –
particularly women who are more likely to receive a smaller valve –
that the SAPIEN platform offers excellent survival and very low
reintervention rates at five years.”
About Edwards
Lifesciences
Edwards Lifesciences is the global leader of patient-focused
innovations for structural heart disease and critical care
monitoring. We are driven by a passion for patients, dedicated to
improving and enhancing lives through partnerships with clinicians
and stakeholders across the global healthcare landscape. For more
information, visit Edwards.com and follow us on Facebook,
Instagram, LinkedIn, Twitter and YouTube.
This news release includes forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933, as amended,
and Section 21E of the Securities Exchange Act of 1934, as amended.
We intend the forward-looking statements contained in this Proxy
Statement to be covered by the safe harbor provisions of such Acts.
These forward-looking statements can sometimes be identified by the
use of forward-looking words, such as “may,” “might,” “believe,”
“will,” “expect,” “project,” “estimate,” “should,” “anticipate,”
“plan,” “goal,” “continue,” “seek,” “intend,” “optimistic,”
“aspire,” “confident” and other forms of these words and include,
but are not limited to, statements made by Mr. Wood and statements
regarding expected product benefits, patient outcomes,
post-treatment reduction of invasive procedures, objectives and
expectations and other statements that are not historical facts.
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. Investors are
cautioned not to unduly rely on such forward-looking
statements.
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 as detailed in the company's filings with the Securities
and Exchange Commission. These filings, along with important safety
information about our products, may be found at Edwards.com.
Edwards, Edwards Lifesciences, the stylized E logo, Edwards
SAPIEN, Edwards SAPIEN 3, PARTNER, PARTNER II, PARTNER 3, SAPIEN,
and SAPIEN 3 are trademarks of Edwards Lifesciences Corporation.
All other trademarks are the property of their respective
owners.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240605540051/en/
Media Contact: Howard Wright, 949-250-2790 Investor Contact:
Mark Wilterding, 949-250-6826
Edwards Lifesciences (NYSE:EW)
Gráfica de Acción Histórica
De Ago 2024 a Sep 2024
Edwards Lifesciences (NYSE:EW)
Gráfica de Acción Histórica
De Sep 2023 a Sep 2024