Next-generation Trifecta valve expands the company's business into the pericardial aortic stented tissue valve segment Approval marks continued progress in Company's 30-year track record in heart valve replacement technologyST. PAUL, Minn., Mar 02, 2010 (BUSINESS WIRE) -- St. Jude Medical, Inc. (NYSE:STJ) today announced that it has received
CE Mark approval for the Trifecta(TM) 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(TM) AC
Technology, an anticalcification treatment designed to reduce tissue
"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.
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
SOURCE: St. Jude Medical, Inc.
St. Jude Medical, Inc.
Angie Craig, 651-756-2191
Marisa Bluestone, 651-756-6739