New Data Presented at EuroPCR 2015 Adds to the Growing Body of Clinical Evidence Supporting St. Jude Medical Fractional Flow ...
May 19 2015 - 8:35AM
Business Wire
Data from the DEFER study demonstrates sustained benefits of FFR
after 15 years, while the CONTRAST study shows contrast FFR offers
superior diagnostic accuracy over iFR
St. Jude Medical, Inc. (NYSE:STJ), a global medical device
company, today announced new results from two clinical studies
further supporting the use of St. Jude Medical fractional flow
reserve (FFR) technology to optimize percutaneous coronary
intervention (PCI) procedures used to restore blood flow to the
heart. The studies – a 15-year follow-up to the DEFER study and
primary results from the CONTRAST study – were presented earlier
today during hotline sessions at EuroPCR 2015. Combined, the
studies contribute to the growing body of evidence supporting FFR
as a valuable and important decision-making tool for
physicians.
Coronary artery disease (CAD) is the most common type of heart
disease, and affects millions of people worldwide. The condition is
caused by a narrowing or blocking of the arteries due to plaque
which restricts blood flow, and reduces the amount of oxygen to the
heart. Physicians often use angioplasty, or PCI, to treat narrowed
vessels and restore blood flow to the heart.
St. Jude Medical’s PressureWire™ FFR technology supports better
treatment decisions for patients by providing a more detailed,
physiologic analysis of blood flow blockages in the heart.
Specifically, FFR can help accurately identify which coronary
lesions or blockages are responsible for obstructing the flow of
blood to a patient’s heart muscle. This insight allows physicians
to determine which lesions warrant stenting, resulting in improved
patient outcomes and reduced health care costs.
The DEFER Study: Demonstrating sustained benefits of FFR
guidance after 15 years
In a 15-year follow up study, new data from the DEFER study
confirms original and five-year findings. Researchers leading the
DEFER study found the positive benefits of decisions based on St.
Jude Medical PressureWire FFR guidance were sustained after 15
years. The study also found the risk for a myocardial infarction
was 6.5 times lower in patients where treatment was guided by FFR
compared to patients in the non-FFR guided group, while finding no
negative effect of leaving non-significant lesions untreated.
The DEFER study’s 15 year data is an important advancement of
FFR, because it confirms sustained benefits of FFR guidance over
time. After 15 years, DEFER researchers found stenting a
non-ischemic stenosis, or narrowing of the blood vessel restricting
blood flow to the heart, had no benefit compared to patients
treated by standard medical therapy. In addition to a reduction in
heart attacks, patients where revascularization was deferred had
very low rates of complications compared to patients in which
lesions were treated without proof of ischemia.
“We are pleased to see the sustained benefits of this study over
15 years. We also find it quite important that there were no
myocardial infarctions as a result of deferring non-significant
lesions, based upon FFR guidance,” said original DEFER investigator
Nico Pijls, M.D., Ph.D., of the Catharina Hospital in Eindhoven,
the Netherlands. “This study confirms the long-term importance of
using FFR to guide PCI and improve the outcome of stenting.”
The CONTRAST Study: Simplifying lesion assessment without
sacrificing accuracy
In the CONTRAST study, researchers assessed FFR differently, and
compared the gold standard in vascular physiologic assessment, FFR
using adenosine, to resting indices (Pd/Pa and iFR) and a new
approach to adenosine-free FFR; FFR using contrast medium. Contrast
FFR (cFFR), also known as contrast Pd/Pa, is a new diagnostic
approach where the hyperemic effect (an increase in blood flow) is
induced by contrast medium in place of adenosine.
The study found that cFFR provides superior accuracy compared to
resting indices such as iFR or resting Pd/Pa. To date, simplifying
physiologic assessment using resting indices has resulted in a
reduction in accuracy, which has limited adoption. The CONTRAST
study found both Pd/Pa and iFR to offer similar rates of accuracy.
In addition, the study’s researchers concluded cFFR did not add
extra cost or procedure time and may be a viable option for
situations where the use of adenosine is undesired or contra
indicated.
“Building upon the strong legacy of landmark evidence supporting
FFR, the DEFER and CONTRAST studies are another important step
forward as St. Jude Medical collaborates with physicians to
generate a robust pool of data supporting FFR as a clinical tool
that can positively impact patient care,” said Mark Carlson, M.D.,
chief medical officer at St. Jude Medical.
About Fractional Flow Reserve (FFR)
FFR 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 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 health
care 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 April 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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version on businesswire.com: http://www.businesswire.com/news/home/20150519006207/en/
St. Jude Medical, Inc.J.C. Weigelt, 651-756-4347Investor
Relationsjweigelt@sjm.comorJustin Paquette, 651-756-6293Public
Relationsjpaquette@sjm.com
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