St. Jude Medical Announces FDA Approval of Trifecta Valve
April 20 2011 - 9:45AM
Business Wire
St. Jude Medical, Inc. (NYSE:STJ), a global medical device
company, today announced that it has received U.S. Food and Drug
Administration (FDA) approval for its Trifecta™ valve. The valve, a
clinically-proven replacement for diseased, damaged or
malfunctioning aortic heart valves, mimics the flow of a natural,
healthy heart and represents a significant new product in the
pericardial aortic stented tissue valve market.
“The Trifecta valve will continue the ongoing transformation of
stented aortic valve replacement,” said Joseph E. Bavaria, M.D.,
Roberts-Measy director and vice chief of cardiovascular surgery at
the University of Pennsylvania in Philadelphia, Pa. “While each new
technology that extends the portfolio of tissue valve solutions for
physicians is critical for enhanced patient care, the Trifecta
valve is a significant step forward for cardiac surgeons in the
United States. The valve is already becoming known for its
exceptional hemodynamic performance, one factor that is
particularly important for the treatment of patients with diseased
aortic heart valves.”
Building upon more than 30 years of St. Jude Medical experience
in developing heart valves, the Trifecta valve was designed for
excellent hemodynamic performance (the optimization of blood flow
through the valve) and long-term durability. To ensure the
structural integrity of the valve, the Trifecta valve is
constructed using a polyester and tissue-covered titanium stent, or
base. The valve features leaflets manufactured from pericardial
tissue attached to the exterior of the valve stent. This design
allows the leaflets to open more fully and efficiently, mimicking
the performance of a healthy aortic heart valve and limiting tissue
abrasion through tissue-to-tissue (stent-to-leaflet) contact. Also
contributing to the valve’s durability, the Trifecta valve offers
the St. Jude Medical patented Linx™ AC Technology, an
anticalcification treatment designed to reduce tissue
mineralization (hardening), one of the primary causes of valve
deterioration.
The Trifecta valve offers several features that improve the ease
of implantation, including the valve’s unique holder, designed to
improve visibility and cuff access for suturing, and customized
sizer, offering physicians more control in choosing the appropriate
replacement valve for each patient’s heart.
“Physicians around the world have already voiced tremendous
excitement and satisfaction with the Trifecta valve,” said Frank J.
Callaghan, president of the St. Jude Medical Cardiovascular
Division. “Trifecta has demonstrated outstanding hemodynamic
performance and has improved the lives of patients with aortic
valve disease. We are proud to continue our legacy of
market-leading valves with this advanced technology and will strive
to continue advancing valve solutions for physicians and patients
around the world.”
Each year, approximately 90,000 patients in the U.S. undergo
open-heart surgery to replace their diseased, damaged heart valves.
The Trifecta stented tissue valve further expands the St. Jude
Medical 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.
The Trifecta valve was approved by regulatory authorities in
Europe and Canada in 2010.
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. St. Jude Medical is headquartered in
St. Paul, Minn. 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 Annual Report on Form 10-K for the fiscal year ended
January 1, 2011. The Company does not intend to update these
statements and undertakes no duty to any person to provide any such
update under any circumstance.
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