IRVINE, Calif., Dec. 21, 2020 /PRNewswire/ -- Edwards
Lifesciences (NYSE: EW), today announced that the first patient has
been treated in the RESTORE clinical trial, which will evaluate the
safety and effectiveness of the investigational HARPOON Beating
Heart Mitral Valve Repair System in the
United States and Canada.
The HARPOON system uses a less-invasive technique than open-heart
surgery in order to treat a type of heart disease called severe
degenerative mitral valve regurgitation, which occurs when there is
damage to the mitral valve that prevents proper functioning of the
valve. The procedure took place at the University of Maryland Medical Center in
Baltimore.
"Symptomatic patients with severe degenerative mitral valve
regurgitation can experience limitations in their day-to-day life
ranging from reduced physical activity to more serious
complications," said Vinod Thourani,
M.D., national principal investigator of the RESTORE trial and
Marcus Chief of Cardiovascular Surgery for Piedmont Healthcare, the
Marcus Heart and Vascular Center and Marcus Heart Valve Center.
"Utilizing less invasive approaches, we can potentially reduce the
need for traditional open-heart surgery and the hardships
associated with a patient's healing and recovery process."
The HARPOON system, which was developed by researchers at the
University of Maryland Heart and
Vascular Center, requires only a small incision to repair the
mitral valve. The procedure is conducted while the heart is still
beating, eliminating the need for a heart bypass machine to do the
work of the heart and lungs while the heart is stopped for
surgery.
"The HARPOON Beating Heart Mitral Valve Repair System is a
testament to Edwards' commitment to the research and development of
innovative, patient-focused technologies that have the potential to
transform cardiac surgery," said Daveen
Chopra, Edwards' corporate vice president, surgical
structural heart. "The RESTORE clinical trial will add to the
growing body of evidence for the HARPOON system, which is also
being evaluated as part of the ASCEND post-market study in
Europe."
The RESTORE clinical trial is an investigational device exempt
study that will enroll and follow up to 360 patients who need
mitral valve repair surgery due to severe degenerative mitral valve
regurgitation. Degenerative mitral valve regurgitation is commonly
caused by mitral valve prolapse, which prevents the valve from
closing properly and causes blood to leak backwards as the heart
contracts. The condition is associated with cardiovascular issues
such as chest pain, shortness of breath and fatigue. In the most
serious cases, it can lead to heart failure.
Patients interested in participating in the RESTORE trial can
visit www.theRESTOREtrial.com for more information, as well as a
list of sites in the U.S. that are currently enrolling
patients.
Caution: Investigational device. Limited by Federal
(United States) law to
investigational use. The device is not available for marketing or
commercial sale in the United
States. Edwards Lifesciences is the sponsor of the RESTORE
trial (IDE G200067).
Dr. Thourani 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.
Thourani 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 and HARPOON
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