Edwards to Begin U.S. Trial of SAPIEN 3 Valve for Intermediate Risk Patients

Edwards to Begin U.S. Trial of SAPIEN 3 Valve for Intermediate Risk Patients 
Enrollment Completed in Trial of High-Risk Patients 
IRVINE, CA -- (Marketwired) -- 01/13/14 --  Edwards Lifesciences
Corporation (NYSE: EW), the global leader in the science of heart
valves and hemodynamic monitoring, today announced that it received
Investigational Device Exemption (IDE) approval from the U.S. Food
and Drug Administration (FDA) to initiate a single-arm,
non-randomized clinical trial of the SAPIEN 3 transcatheter aortic
heart valve in the treatment of intermediate risk patients with
severe symptomatic aortic stenosis. The company also completed
enrollment in its U.S. clinical trial studying the SAPIEN 3 valve in
the treatment of high-risk or inoperable patients.  
The SAPIEN 3 valve is the only transcatheter heart valve available to
U.S. patients that can be delivered through a low-profile 14-French
expandable sheath (eSheath). It also has an outer skirt -- a cuff of
fabric surrounding the bottom of the frame -- to provide a seal to
address paravalvular leak. The SAPIEN 3 valve can be implanted with
the transfemoral approach through an incision in the leg, as well as
alternative access approaches. It is an investigational device that
is not available commercially in any country; CE Mark approval in
Europe is anticipated in the near future. 
The new U.S. trial of the SAPIEN 3 valve will enroll up to 1,000
patients with a Society of Thoracic Surgeons score of four to eight
percent, which indicates the average predicted risk of operative
mortality at 30 days. All enrolled patients can receive a SAPIEN 3
valve. 
"The SAPIEN 3 valve is a significant advancement, and we're excited
to make progress toward bringing this sought-after transcatheter
therapy to U.S. patients. It represents a big step toward fulfilling
the promise of a simpler procedure with fewer complications and
faster patient recovery," said Larry L. Wood, corporate vice
president, transcatheter heart valves. "Last year, we completed
enrollment in the first U.S. randomized controlled trial involving
intermediate risk patients with severe aortic stenosis. This unique
dataset of 2,000 patients receiving surgery or transcatheter valve
replacement will provide a thorough baseline comparison for this new
stu
dy of the SAPIEN 3 valve in intermediate risk patients." 
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, Mr. Wood's statements,
statements regarding the expected timing of CE Mark approval for
SAPIEN 3, and statements regarding expected outcomes of the clinical
trial and anticipated benefits of SAPIEN 3. 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, unexpected delays or changes in the
clinical trial, unanticipated outcomes of the trial or longer term
clinical experience with the product, or unanticipated quality or
regulatory delays or issues. 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, 2012. 
Edwards, Edwards Lifesciences, the stylized E logo, Edwards SAPIEN 3
and SAPIEN 3 are trademarks of Edwards Lifesciences Corporation. 
Media Contact:
Sarah Huoh
949-250-5070 
Investor Contact: 
David K. Erickson
949-250-6826 
 
 
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