Adjustable repair ring enables a more individualized repair
ST. PAUL, Minn.--(BUSINESS WIRE)--May. 6, 2009--
St. Jude Medical, Inc. (NYSE:STJ) today announced the U.S. launch of its
Attune™ Flexible Adjustable Annuloplasty Ring for the repair
of diseased heart valves. The company received U.S. Food and Drug
Administration clearance and will introduce the product at the annual
meeting of the American Association for Thoracic Surgery in Boston, on
May 9.
The mitral valve controls the flow of oxygenated blood between the upper
and lower chambers of the heart. When a mitral valve malfunctions due to
infection, heart attack damage, a congenital condition or other cause,
the valve no longer closes tightly because its leaflets (flaps that open
and shut) become misaligned, allowing blood to regurgitate, or “leak”
backward. Without treatment, a leaky heart valve can lead to irregular
heartbeat, clotting, stroke and heart failure. Cardiac surgeons use a
variety of techniques to restore proper leaflet closing and alignment,
including annuloplasty: implanting a ring around the circular base of
the valve to support the repair.
The Attune ring is a flexible annuloplasty ring designed to support a
repair of the heart’s mitral valve. The ring’s flexibility allows the
annulus to continue its natural movement as the valve opens and closes,
thus contributing to more physiologic valve function. The ability to
adjust the ring post-implant promotes ideal leaflet alignment to reduce
or eliminate residual regurgitation, or small leaks after the repair.
Unlike most other flexible annuloplasty rings that have a fixed size,
the Attune ring can be adjusted after it is sutured to the annulus – a
feature that allows physicians greater control in altering its size and
shape to contribute to a more refined repair specific to fit each
patient’s heart valve anatomy. The Attune ring is suitable for repairs
performed with open chest, minimally invasive or robotic surgical
approaches.
“The surgeon’s goal in mitral valve repair is to restore the natural
function of the valve. The thin, flexible Attune ring allows the normal
physiologic changes in annular shape to be preserved. The adjustability
is designed to allow the surgeon to fine tune the annular diameter to
optimize leaflet apposition and help ensure a successful repair,” said
John A. Spratt, M.D., Cardiothoracic Surgeon at Roper Hospital,
Charleston, S.C.
Guidelines issued in 2006 by the American Heart Association and the
American College of Cardiology encourage heart valve repair over
replacement when possible, and recommend repair earlier in the valvular
disease process. An estimated 37,600 Americans underwent heart valve
repair in 2008, according to Millennium Research Group. This number is
projected to increase approximately five percent each year as the age of
the population increases.
“By offering a comprehensive portfolio of valve repair products and
introducing a new level of adjustability in our latest offering, St.
Jude Medical is providing physicians options that allow them greater
control in performing procedures and achieving excellent patient
outcomes,” said Frank Callaghan, president of the St. Jude Medical
Cardiovascular Division. “We continue to invest in cardiac surgery
technology to better assist physicians in the treatment of the entire
spectrum of heart valve disease, including repair products, a
comprehensive offering of gold-standard mechanical valves and durable
stented tissue valves.”
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
approximately 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 www.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 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.
Source: St. Jude Medical, Inc.
St. Jude Medical, Inc.
Investor Relations:
Angela Craig,
651-481-7789
acraig@sjm.com
or
Media
Relations:
Amy Jo Meyer, 651-766-3029
ameyer@sjm.com
