New Clinical Trial Results Demonstrate Importance of St. Jude Medical Fractional Flow Reserve in Guiding Treatment of NSTEMI ...
September 01 2014 - 2:42PM
Business Wire
FAMOUS-NSTEMI is the latest clinical trial to
assess benefits of St. Jude Medical PressureWireTM technology in
expanded patient populations
St. Jude Medical, Inc. (NYSE:STJ), a global medical device
company, today announced a new multi-center clinical trial has
found that using St. Jude Medical Fractional Flow Reserve (FFR)
technology changed the course of treatment for more than one fifth
of patients suffering non-ST segment elevation myocardial
infarction (NSTEMI) heart attacks. The data also demonstrated that
FFR-guided PCI is safe and tended to reduce procedure-related
myocardial infarctions in NSTEMI patients over angiography alone.
NSTEMI is the most common form of acute coronary syndrome and a
leading cause of premature morbidity and mortality worldwide.
The data were presented during a hot line late-breaking session
at the European Society of Cardiology Congress 2014 and appears in
the online version of the European Heart Journal.
FFR technology allows physicians to more accurately assess the
severity of blood flow blockages in the coronary arteries and
determine which lesions require treatment. Previous clinical
studies have demonstrated St. Jude Medical FFR technology can
improve patient outcomes and reduce medical costs in patients with
stable coronary artery disease (CAD).
Now, in a study of 350 patients suffering NSTEMI heart attacks,
St. Jude Medical PressureWireTM FFR measurement technology is
credited with altering the treatment strategy of approximately 22
percent of patients. The study also demonstrated a trend toward a
reduction in procedure-related myocardial infarction among patients
whose therapy was guided by FFR using St. Jude Medical
PressureWireTM technology.
“In patients suffering NSTEMI, traditional diagnostic imaging
tools have limited our ability to optimally assess which blockages
require revascularization,” said Dr. Colin Berry, a Professor of
Cardiology and Imaging at the University of Glasgow and Principal
Investigator of the FAMOUS-NSTEMI clinical trial. “What we’ve now
found is fractional flow reserve technology has additive diagnostic
and clinical benefits for NSTEMI patients. We need to continue to
evaluate the technology’s potential in new segments of
patients.”
The FAMOUS-NSTEMI trial is the first comprehensive clinical
assessment of the ability of PressureWireTM FFR technology to guide
treatment in patients suffering NSTEMI. Currently, physicians
treating NSTEMI patients at a high risk for serious cardiac
complications will often opt for a treatment strategy that relies
on coronary angiography to assess blood flow within the arteries of
the heart. FFR represents a new approach to managing NSTEMI
patients because it relies less on subjective visual assessments of
angiography and instead offers an objective physiological
assessment of blood flow blockages.
“Using St. Jude Medical PressureWire, physicians can leverage
FFR to better assess the need for interventional procedures and
more accurately identify lesions that require stenting,” said Dr.
Mark Carlson, chief medical officer at St. Jude Medical. “The
clinicians leading the FAMOUS-NSTEMI study have now confirmed that
a new group of patients can benefit from FFR.”
The FAMOUS-NSTEMI trial enrolled 350 patients in six U.K.
hospitals between October 2011 and May 2013. Patients enrolled had
at least one coronary stenosis at least 30 percent occluded at time
of admission for NSTEMI. In patients randomized to the FFR-guided
group, an FFR of greater than 0.80 indicated revascularization by
PCI or coronary bypass surgery.
About the FAME Trials
The FAMOUS-NSTEMI study builds on data from the FAME and FAME 2
clinical trials, which support FFR as the standard of care for the
treatment of patients with coronary artery disease (CAD).
The original FAME trial, which concluded in 2008, found FFR
allows for more accurate identification of narrowed passages most
likely to cause a coronary event, reducing rates of death,
myocardial infarction (heart attack) and repeat
revascularization.
Preliminary data from FAME 2 further supported FFR, and found
FFR-guided PCI with PressureWireTM measurement technology is a
cost-effective strategy that can improve clinical outcomes and
quality of life in patients with stable coronary artery disease
(CAD) over medical therapy alone. Results of both the FAME and FAME
2 trials were published in The New England Journal of
Medicine.
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
December 28, 2013 and Quarterly Report on Form 10-Q for the fiscal
quarter ended June 28, 2014. The Company does not intend to update
these statements and undertakes no duty to any person to provide
any such update under any circumstance.
St. Jude Medical, Inc.J.C. Weigelt, 651-756-4347Investor
Relationsjweigelt@sjm.comorJustin Paquette, 651-756-6293Media
Relationsjpaquette@sjm.com
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