New Data Presented at EuroPCR 2016 Adds to the Growing Body of Clinical Evidence Supporting St. Jude Medical FFR Technology &...
May 19 2016 - 4:47AM
Business Wire
St. Jude Medical, Inc. (NYSE:STJ), a global medical device
company, today announced results from two cardiovascular clinical
trials presented at EuroPCR 2016. The studies, which include a look
at how St. Jude Medical™ fractional flow reserve (FFR) technology
impacts patient outcomes in Acute Coronary Syndrome (ACS) and a
comparison of left atrial appendage occlusion (LAAO) therapy to
standard medical treatment – were presented during hotline
sessions.
The latest studies contribute to the growing body of evidence
supporting two important St. Jude Medical cardiovascular therapies:
FFR guidance with St. Jude Medical PressureWire™ technology to
optimize percutaneous coronary intervention (PCI) procedures in
patients with narrowed or blocked coronary arteries, as well as
left atrial appendage closure for patients at increased risk of
stroke as a result of atrial fibrillation. St. Jude Medical has
been an international leader in LAAO therapy, originally offering
the AMPLATZER™ Cardiac Plug (ACP) for LAAO and now offering the
AMPLATZER™ Amulet™ Left Atrial Appendage Occluder.
PRIME-FFR Study showcases the benefits of FFR in the
Treatment of ACS
Presented today at a EuroPCR Hotline session, the PRIME-FFR
study aimed to quantify the value of FFR when deciding the most
appropriate treatment for patients with ACS. In the medical
community, ACS is an umbrella term for medical conditions where
blood supply to the heart is suddenly blocked. According to the
American Heart Association, the blockage can be sudden and clog the
entire artery or it can be a moving clot that causes temporary
blockage and decreased blood supply. The condition is more commonly
referred to as a heart attack and needs to be addressed by a
physician immediately.
In assessing the value of FFR, the study’s investigators defined
management strategies for patients based on angiography results
before performing FFR, and then made a final treatment strategy
decision after performing FFR. Results showed that management
strategy reclassification after performing routine FFR was high and
that FFR is safe to use in ACS patients, indicating a management
strategy guided by FFR safely leads to changes in physician
decision making.
“These data further support the benefits of the St. Jude Medical
fractional flow reserve portfolio and show that using our
fractional flow reserve technology as part of a management plan
helps physicians make informed treatment decisions,” said Dr. Mark
Carlson, chief medical officer and vice president of global medical
affairs at St. Jude Medical. “We are committed to providing the
best treatment options for our patients and technology like this
allows us to do so.”
Assessing the impact of St. Jude Medical’s LAAO technology
versus standard medical therapy in patients with atrial
fibrillation and intracerebral hemorrhage
In a hotline presentation at EuroPCR, researchers assessed the
impact of a LAAO in patients with atrial fibrillation (AF) and
intracerebral hemorrhage (ICH) versus patients who received
standard medical therapy. The left atrial appendage (LAA) is a
small pouch that hangs from the left atrium, which is considered to
be unproblematic for most people with a regular heart rhythm.
However, patients with AF experience a chaotic, uncontrolled heart
rhythm, which can increase the likelihood of clot formation in the
LAA, potentially resulting in a stroke. Because AF leads to an
increased risk of stroke, a physician may seal off the LAA with an
LAA Occluder, or prescribe oral anticoagulants (OAC) to potentially
reducing that risk.
While OACs are proven to be effective in reducing the risk of
stroke in patients with AF, this therapy carries the risk of ICH,
or recurrent bleeding, which is the leading cause of stroke
mortality. Because the risk of reoccurring ICH is increased among
patients who have previously experienced an ICH, many of these
patients are denied OAC.
The LAAO in AF and ICH study found that patients with AF and a
prior ICH who were treated with a St. Jude Medical LAAO device had
a lower risk of ischemic stroke, major bleeding and all-cause
mortality compared to patients treated with standard care,
suggesting that LAAO offers a major clinical benefit.
“Patients with atrial fibrillation and previous intracerebral
hemorrhage have an increased risk of ischemic stroke or repeated
hemorrhage,” said Jens Erik Nielsen-Kudsk, M.D., DMSc, an associate
professor of cardiologic medicine at Aarhus University and the
study’s lead author. “The data from the this latest clinical
assessment further shows that having a device like the AMPLATZER
LAA occlusion device implanted in these patients’ hearts offers
them additional opportunity for improved cardiac health.”
About St. Jude Medical
St. Jude Medical is a leading global medical device manufacturer
and is 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 employs approximately 18,000 people
worldwide and has five major areas of focus that include heart
failure, atrial fibrillation, neuromodulation, traditional cardiac
rhythm management and cardiovascular. 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 2, 2016 and Quarterly Report on Form 10-Q for the fiscal
quarter ended April 2, 2016. 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/20160519005499/en/
St. Jude Medical, Inc.J.C. Weigelt, 651-756-4347Investor
Relationsjweigelt@sjm.comorLaurel Hood, 651-756-2853Media
RelationsLHood02@sjm.com
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