AUSTIN, Texas, Jan. 31, 2021 /PRNewswire/ -- Edwards
Lifesciences (NYSE: EW) today announced new data from the COMMENCE
clinical trial that demonstrate Edwards' bioprosthetic surgical
aortic valve with the company's novel RESILIA tissue platform show
favorable safety and hemodynamic performance through a median of
five years follow-up. The data were presented at the 57th annual
meeting of the Society of Thoracic Surgeons.
"There continues to be a significant focus placed on tissue
valve durability given the increase in life expectancy and
lifestyle implications for more active patients who historically
would receive mechanical valves," said Joseph E. Bavaria, M.D.,
lead enroller and site principal investigator for the COMMENCE
study and the Brooke Roberts-William M.
Measey professor of surgery and vice chief of the division
of cardiovascular surgery, University of
Pennsylvania. "The latest data from the COMMENCE study are
encouraging and speak to the promise of RESILIA tissue as a
significant advancement in technology for patients with valve
disease."
There were no incidences of structural valve deterioration (SVD)
at the five-year review mark, a key safety outcome. SVD can be
caused by a buildup of calcium on the valve's tissue or by other
damage that impacts long-term durability of the valve. RESILIA
tissue is specially formulated using a proprietary
integrity-preservation technology that may eliminate a key factor
in calcification leading to valve deterioration.
"Beyond the COMMENCE study, Edwards continues to invest in
research to examine different outcome measures to further validate
the long-term performance and durability of RESILIA tissue," said
Daveen Chopra, Edwards' corporate
vice president, surgical structural heart. "Evidence from the
COMMENCE trial adds to the growing body of research that
demonstrates the value of innovative, RESILIA tissue-based
technologies in transforming care for patients, especially more
active patients."
Current technologies utilizing this novel tissue include the
INSPIRIS RESILIA aortic valve and the KONECT RESILIA aortic valved
conduit, the first ready-to-implant solution for bio-Bentall
procedures. In addition to its anti-calcification properties,
RESILIA tissue also allows the valve to be stored under dry
packaging conditions, facilitating ease of use in the operating
room.
The COMMENCE study is a prospective, non-randomized,
multicenter, single-arm investigational device exemption (IDE)
trial comprised of 689 patients at 27 clinical sites across
the United States and Europe. The trial
evaluated the safety and effectiveness of Edwards' RESILIA tissue
aortic valve in patients ages 18 and older with diagnosed aortic
valve disease and scheduled to undergo aortic valve replacement
surgery. Data were collected for a total of five years and a
subset of these patients will continue to be evaluated through 10
years. At this stage, the study has recorded data equivalent to
2,989 patient-years of follow-up.
Additional RESILIA tissue studies include:
- European feasibility study: a prospective, single-arm
observational clinical trial that evaluated SVD in a cohort of 133
patients. There were no events of structural valve deterioration
throughout the study period of five years.
- RESILIENCE clinical trial: an ongoing, first-of-its-kind study
designed to assess calcium deposits as a way to potentially predict
long-term bioprosthetic valve durability. The study will enroll up
to 250 patients under the age of 65 at the time of surgery to
examine incidence of valve deterioration from year five to 11 after
surgery.
Dr. Bavaria is a consultant to Edwards Lifesciences.
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 and Section
21E of the Securities Exchange Act of 1934. These forward-looking
statements include, but are not limited to statements made by Dr.
Bavaria and Mr. Chopra and statements regarding expected product
benefits, patient outcomes, future plans related to the product
lines, 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 including its Annual Report on Form 10-K
for the year ended December 31, 2019
and the Quarterly Report on Form 10-Q for the quarter ended
March 31, 2020. These filings, along
with important safety information about our products, may be found
at edwards.com.
Edwards, Edwards Lifesciences, the stylized E logo, Edwards
RESILIA, COMMENCE, INSPIRIS, INSPIRIS RESILIA, and KONECT are
trademarks of Edwards Lifesciences Corporation. All other
trademarks are the property of their respective owners. This
statement is made on behalf of Edwards Lifesciences Corporation and
its subsidiaries.
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SOURCE Edwards Lifesciences Corporation