St. Jude Medical Receives CE Mark Approval for Trifecta Valve
March 02 2010 - 6:58AM
Business Wire
St. Jude Medical, Inc. (NYSE:STJ) today announced that it has
received CE Mark approval for the Trifecta™ valve, marking the
Company’s launch into the market for pericardial aortic stented
tissue valves.
The Trifecta tissue valve is used to replace a patient’s
diseased, damaged or malfunctioning aortic heart valve, which
controls blood flow from the heart to the rest of the body. The
next-generation tissue valve has a tri-leaflet stented pericardial
design which offers excellent hemodynamic performance, or nearly
unobstructed blood flow, in order to mimic as closely as possible
the flow of a natural, healthy heart. The unique valve design
includes leaflets manufactured from pericardial tissue attached to
the exterior of the valve stent which open more fully and
efficiently to perform like a natural heart valve.
For more than 30 years, St. Jude Medical has offered patients
the gold standard in mechanical heart valve performance and
durability, and has developed the Trifecta valve using the same
market-leading expertise. The valve’s titanium stent, which
provides a fatigue resistant frame to support the valve within a
patient’s heart, is covered with pericardial tissue to allow
tissue-to-tissue contact when the leaflets open and close, which
reduces the amount of wear and deterioration. Additional attributes
contributing to the Trifecta valve’s durability include proprietary
tissue fixation and St. Jude Medical’s patented Linx™ AC
Technology, an anticalcification treatment designed to reduce
tissue mineralization (hardening).
“The Trifecta valve’s superior hemodynamic performance helps to
make it very attractive for aortic valve replacement, especially in
a small aortic annulus,” said Professor Volkmar Falk, Chair of the
Division of Cardiac and Vascular Surgery at University Hospital
Zurich. “The construction and design of the Trifecta valve allows
it to work seamlessly with the patient’s heart to generate adequate
blood flow, which can offer patients an improved quality of
life.”
With nearly 3.4 million patients in Europe suffering from aortic
stenosis, the Trifecta valve is available in a wide range of sizes
to offer physicians more control in choosing the appropriate
replacement valve for each patient’s heart. The Trifecta stented
tissue valve further expands St. Jude Medical’s valve product
portfolio which includes market-leading mechanical heart valves,
valve annuloplasty rings and porcine tissue valves with superior
durability for both the aortic and mitral valve.
“St. Jude Medical has long been dedicated to the development of
heart valves that offer patients a best-in-class option for their
care. For many years we have dedicated significant resources to
develop better heart valve replacement technology, and the Trifecta
valve is one culmination of that effort. Trifecta has been
specifically designed for improved hemodynamics, durability and
implantability, and we are proud to offer it to the cardiac surgery
community,” said Frank Callaghan, president of St. Jude Medical’s
Cardiovascular Division. “The Trifecta valve marks an important
milestone for St. Jude Medical, and it reflects our commitment to
developing products which improve physician control, reduce patient
risk and improve patient outcomes.”
About St. Jude Medical
St. Jude Medical develops medical technology and services that
focus on putting more control into the hands of those who treat
cardiac, neurological and chronic pain patients worldwide. The
company is dedicated to advancing the practice of medicine by
reducing risk wherever possible and contributing to successful
outcomes for every patient. Headquartered in St. Paul, Minn., St.
Jude Medical employs more than 14,000 people worldwide and has four
major focus areas that include: cardiac rhythm management, atrial
fibrillation, cardiovascular and neuromodulation. For more
information, please visit sjm.com.
Forward-Looking Statements
This news release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995
that involve risks and uncertainties. Such forward-looking
statements include the expectations, plans and prospects for the
Company, including potential clinical successes, anticipated
regulatory approvals and future product launches, and projected
revenues, margins, earnings and market shares. The statements made
by the Company are based upon management’s current expectations and
are subject to certain risks and uncertainties that could cause
actual results to differ materially from those described in the
forward-looking statements. These risks and uncertainties include
market conditions and other factors beyond the Company’s control
and the risk factors and other cautionary statements described in
the Company’s filings with the SEC, including those described in
the Risk Factors and Cautionary Statements sections of the
Company’s Quarterly Reports on Form 10-Q for the fiscal quarters
ended April 4, 2009, July 4, 2009 and October 3, 2009. The Company
does not intend to update these statements and undertakes no duty
to any person to provide any such update under any
circumstance.
SJM (NYSE:STJ)
Historical Stock Chart
From Jun 2024 to Jul 2024
SJM (NYSE:STJ)
Historical Stock Chart
From Jul 2023 to Jul 2024