FAMOUS-NSTEMI is the latest clinical trial to assess benefits of St.
Jude Medical PressureWireTM technology in expanded patient
populations
Company Website:
http://www.sjm.com/esc
ST. PAUL, Minn. & BARCELONA, Spain -- (Business Wire)
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.
Contacts:
St. Jude Medical, Inc.
J.C. Weigelt, 651-756-4347
Investor
Relations
jweigelt@sjm.com
or
Justin
Paquette, 651-756-6293
Media Relations
jpaquette@sjm.com
Source: St. Jude Medical, Inc.
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