St. Jude Medical Announces European Approval of First and Only Combined FFR and OCT System
July 14 2011 - 8:00AM
Business Wire
St. Jude Medical, Inc. (NYSE:STJ), a global medical device
company, today announced it has received European CE Mark approval
for its ILUMIEN™ system, the first integrated diagnostic technology
that combines optical coherence tomography (OCT) and fractional
flow reserve (FFR) technologies on one platform. The combined
system offers physicians advanced physiological and anatomical
insight to improve the diagnosis and treatment of coronary artery
disease.
The ILUMIEN system features the St. Jude Medical PressureWire™
Aeris, a wireless interventional tool that measures FFR to evaluate
the severity of blood flow blockages in the coronary arteries, and
the St. Jude Medical C7-XR™ OCT diagnostic imaging technology with
Extreme Resolution™, a first-to-market intravascular imaging
technology that allows physicians to visualize and measure
important vessel characteristics otherwise not visible or difficult
to assess with older intracoronary imaging technologies. Combined,
the two technologies enable the optimization of percutaneous
coronary intervention (PCI) by assisting physicians in identifying
culprit lesions responsible for ischemia (coronary narrowings
responsible for significantly obstructing the flow of blood to a
patients' heart muscle) and by providing physicians with precise
measurements of lesion dimensions and vessel size and
structure.
“The ILUMIEN system provides me and my colleagues with an
easy-to-use, flexible solution that combines OCT and FFR technology
on one system,” said Dr. Evelyn Regar, M.D., Ph.D., FESC, Associate
Professor, Department of Interventional Cardiology Thoraxcenter in
Rotterdam, Netherlands. “Having these two cutting edge technologies
together is a welcome advancement for therapy guidance, allowing me
to choose the right tools for each patient situation.”
Additionally, the St. Jude Medical ILUMIEN system features the
Wi-Box™, a wireless device that enables the ILUMIEN system to
receive data (aortic pressure readings) from the catheterization
lab wirelessly. The Wi-Box allows physicians and staff a completely
cable-free FFR solution, combining the ease of use of a built-in
system with the cost efficiency of a mobile platform.
“Knowing which lesion to treat and how to treat it is the key to
optimizing interventional treatment strategies,” said Frank J.
Callaghan, president of the St. Jude Medical Cardiovascular
Division. “We believe integrating these technologies is key to
providing physicians a simplified, streamlined option for the
diagnosis and treatment of patients with coronary artery
disease.”
The C7-XR System with the C7 Dragonfly™ Imaging Catheter and the
PressureWire Aeris were launched in Europe in 2009.
About Fractional Flow Reserve (FFR)
Fractional Flow Reserve (FFR) is an index determining the
functional severity of narrowings in the coronary arteries as
measured by PressureWire Certus and PressureWire Aeris. FFR
specifically identifies which coronary narrowings are responsible
for significantly obstructing the flow of blood to a patients'
heart muscle (called ischemia), and it is used by the
interventional cardiologist to direct coronary interventions and
assess results for improved treatment outcomes.
Current data show that physiological assessment using FFR prior
to placement of coronary stents helps physicians better optimize
clinical outcomes by determining which specific lesion or lesions
are responsible for a patient's ischemia. In January 2009, St. Jude
Medical announced results from the landmark FAME (Fractional Flow
Reserve (FFR) vs. Angiography in Multivessel Evaluation) study, a
randomized, prospective, multi-center trial. The study enrolled
1,005 patients with multivessel coronary artery disease and
compared outcomes for patients whose treatment was guided by FFR to
those whose treatment was guided only by angiography. The 12-month
results, published in the January 15, 2009 issue of the New England
Journal of Medicine, demonstrated that instances of major adverse
cardiovascular events (MACE), such as death, myocardial infarction
or repeat revascularization, were reduced by 30 percent for
patients whose treatment was guided by FFR rather than by standard
angiography alone.
About Optical Coherence Tomography (OCT)
Optical Coherence Tomography (OCT) is a leading imaging
technology platform that aids physicians in the diagnosis and
treatment of cardiovascular disease. OCT utilizes near-infrared
light to create images to visualize and measure important vessel
characteristics otherwise not visible or difficult to assess with
older intracoronary imaging technologies- such as fluoroscopy and
intravascular ultrasound (IVUS). OCT can be especially important
for the assessment of stent placement because the high-resolution
images show precisely how the stent is holding the artery open and
whether it is positioned correctly against the artery wall,
optimizing treatment and follow-up strategies.
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 and Quarterly Report on Form 10-Q for the fiscal
quarter ended April 2, 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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