Data presented at the ESC Congress 2015 contributes to the growing body
of long term clinical evidence supporting St. Jude Medical PressureWire
Fractional Flow Reserve technology
Company Website:
http://www.sjm.com
ST. PAUL, Minn. & LONDON -- (Business Wire)
St. Jude Medical, Inc. (NYSE:STJ), a global medical device company,
today announced that five year results from the landmark FAME trial
(Fractional Flow Reserve vs. Angiography in Multivessel Evaluation) have
confirmed the long term benefits of fractional flow reserve (FFR) in
guiding percutaneous coronary intervention (PCI) over angiography alone.
An analysis of the study’s five year follow up data confirms that in
patients with multi-vessel coronary artery disease, FFR-guided PCI can
contribute to reductions in all-cause mortality, cardiac mortality and
an overall use of health care resources.
The data, which were presented at the ESC Congress 2015, build upon
previously-published results from the St. Jude Medical sponsored FAME
trial at 12-months and two-year follow up intervals.
“Original 12 month results from the FAME trial and the study’s two year
follow-up data demonstrated clearly that PCI guided by fractional flow
reserve results in a significant reduction in major adverse cardiac
events for patients undergoing PCI,” said the FAME study’s principal
investigator, Nico H.J.Pijls, M.D., Ph.D., of Catharina Hospital in
Eindhoven, The Netherlands. “Now, the study’s five year follow up data
have given us a critical look at the impact of FFR guidance over time.
We’ve proven that the benefits are sustained and can dramatically impact
the long-term wellbeing and clinical outcomes of patients as compared to
only using angiography to guide intervention.
After five years of patient follow up, FAME researchers have found that
FFR guidance using St. Jude Medical PressureWire™ technology can lead to
a more favorable treatment and clinical decision making, which can
result in fewer events in the first two years and a sustained benefit up
to five years. In addition, five year follow up data from the FAME trial
demonstrate:
- Improved patient outcomes. In patients with multi-vessel
coronary artery disease, FFR-guided PCI resulted in a 27 percent
relative reduction of cardiac mortality versus angiography alone.
- An overall decline in adverse events. Adverse events among
patients who received FFR-guided PCI consistently decreased compared
to patients who received angiography-guided PCI.
- FFR’s positive economic impact on health care cost. Five year
data from the FAME trial further supports the positive economic impact
and reduction of health care resource utilization shown by the
original results of the study.
“The five year data from the FAME study build upon our understanding of
applying FFR to guide the care of patients battling coronary artery
disease, and this study has continued to demonstrate that St. Jude
Medical’s PressureWire technology can improve patient outcomes and the
clinical benefits of PCI, while reducing costs for the health care
system,” said Mark Carlson, M.D., chief medical officer at St. Jude
Medical. “FFR technology provides physicians with the insight they need
to make improved clinical decisions for their patients.”
Coronary artery disease is the most common form of heart disease and the
leading cause of death for both men and women worldwide. The condition
is caused by plaque build-up in the arteries, which can narrow blood
vessels and block blood flow to the heart. During PCI procedures, FFR is
used to provide physicians with a detailed analysis of the blood flow
blockage to make decisions on how to best keep the artery expanded to
restore blood flow to the heart and to determine whether coronary
intervention – such as stenting, is necessary.
About the FAME Trial
The original FAME (Fractional Flow Reserve (FFR) vs. Angiography in
Multivessel Evaluation) Trial compared outcomes of patients whose
treatment was guided by FFR to those whose treatment was only guided by
angiography. Results from the landmark trial demonstrated improved
clinical outcomes in patients with stable coronary artery disease and
two or three vessel disease.
The 12 month results published in the New England Journal of
Medicine demonstrated that instances of major adverse cardiac events
were reduced by 28 percent for patients whose treatment was guided by
FFR rather than by standard angiography alone. Two year results
demonstrated that patients who received FFR-guided treatment continued
to experience improved outcomes over time, including a 34 percent risk
reduction in death or heart attack.
About Fractional Flow Reserve
Fractional flow reserve is a physiological index used to determine the
hemodynamic severity of narrowings (or lesions) in the coronary
arteries, and is measured using St. Jude Medical PressureWire™ Aeris™
and PressureWire™ Certus™ FFR measurement system. FFR specifically
identifies which coronary narrowings are responsible for obstructing the
flow of blood to a patient’s heart muscle (called ischemia), and helps
guide the interventional cardiologist in determining which lesions
warrant stenting, resulting in improved patient outcomes and reduced
healthcare costs.
About St. Jude Medical
St. Jude Medical is a global medical device manufacturer dedicated to
transforming the treatment of some of the world’s most expensive
epidemic diseases. The company does this by developing cost-effective
medical technologies that save and improve lives of patients around the
world. Headquartered in St. Paul, Minn., St. Jude Medical has four major
clinical focus areas that include cardiac rhythm management, atrial
fibrillation, cardiovascular and neuromodulation. For more information,
please visit sjm.com or
follow us on Twitter @SJM_Media.
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, 2015 and Quarterly Report on
Form 10-Q for the fiscal quarter ended July 4, 2015. 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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Contacts:
St. Jude Medical, Inc.
Investor Relations:
J.C. Weigelt,
651-756-4347
jweigelt@sjm.com
or
Media
Relations
Matt Puplett, 651-756-6293
mpuplett@sjm.com
Source: St. Jude Medical, Inc.
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