St. Jude Medical Announces European Launch of the Latest in PressureWire Guidewire Technology to Measure Pressure Differences...
May 18 2016 - 08:00AM
Business Wire
The new PressureWire™ X Guidewire is designed to adapt to
unique, complex anatomies and improve FFR measurement
St. Jude Medical, Inc. (NYSE:STJ), a global medical device
company, today announced CE Mark approval and European launch of
the PressureWire™ X Guidewire fractional flow reserve (FFR)
Measurement System. Designed to identify the severity of narrowings
in the coronary arteries of patients with coronary artery disease
(CAD), FFR measurement allows for a more effective assessment of
coronary lesions (blockages), resulting in more accurate diagnosis.
The company will showcase the new PressureWire X guidewire
technology at the EuroPCR 2016 meeting, May 17-20, 2016 in Paris.
The PressureWire X guidewire European launch will include a
measured rollout to targeted countries throughout 2016.
PressureWire™ FFR guidewire measurement supports more accurate
lesion assessment during percutaneous coronary intervention (PCI)
to help physicians make more informed treatment decisions for their
patients, which has been shown to improve patient outcomes. The
newly launched PressureWire X guidewire offers enhanced durability
and improved handling in either a cabled or wireless configuration,
both with the accuracy and reliability physicians need when
treating patients with CAD.
“Fractional flow reserve has become an indispensable tool for
assessing coronary lesions and making informed treatment decisions
during percutaneous coronary intervention,” said Dr. Bernard De
Bruyne of the CVC Aalst, Belgium. “The improved design of the new
PressureWire X guidewire tip will simplify the fractional flow
reserve procedure by enabling access to lesions in patients with
tortuous, complex anatomy.”
Designed to provide better durability and shape retention than
currently available pressure guidewires, the new PressureWire X
guidewire aims to provide physicians with a tip that can be shaped
and re-shaped during PCI, which enables it to be used to assess
multiple lesions, even in patients with complex anatomy. Allowing
physicians to better navigate each patient’s unique anatomy will
support improved assessment and diagnosis of coronary blockages,
which can lead to improved decision-making on how best to restore
blood flow to the heart. The latest PressureWire X guidewire is
also intended to support faster procedure times, ensuring patients
undergo more efficient PCI procedures.
The use of FFR to optimize PCI is supported by strong evidence,
such as the FAME (Fractional
Flow Reserve (FFR) vs. Angiography in Multivessel Evaluation) trials, which found that St.
Jude Medical™ PressureWire™ technology can improve patient outcomes
over angiography alone in patients with CAD. The FAME body of
evidence also demonstrated reductions in the risk of death or heart
attack in patients undergoing PCI, as well as reduced health care
costs for patients whose treatment was guided by FFR
technology.
In addition to clinical trails designed to assess the positive
outcomes associated with FFR technology, St. Jude Medical has
launched the PRESSUREwire REGISTRY (Practical Evaluation of Fractional Flow
Reserve (FFR) and its Association
Alternate Indices During Routine Clinical Procedures), a multicenter clinical trial to
determine the routine use of FFR measurement and clinical outcomes
of FFR-guided PCI in patients with acute coronary syndrome (ACS), a
major cause of global morbidity and mortality.
“St. Jude Medical strives to provide physicians with fractional
flow reserve pressure guidewire options that are backed by clinical
data and match the handling performance of conventional workhorse
PCI guidewires, which is a combination that we have always
prioritized in designing and developing the PressureWire series of
FFR guidewires,” said Dr. Mark Carlson, chief medical officer and
vice president of global medical affairs at St. Jude Medical. “The
new PressureWire X guidewire shows our dedication to providing
physicians with cost-effective, easy-to-use technologies that aid
them in making the best treatment decisions for their
patients.”
About the Original FAME Trial
The original St. Jude Medical sponsored 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 (FFR)
Fractional Flow Reserve (FFR) is an index determining the
functional severity of narrowings in the coronary arteries, and it
is measured by PressureWire™ Aeris™ or PressureWire™ Certus™ FFR
measurement system. FFR specifically identifies which coronary
narrowings are responsible for significantly obstructing the flow
of blood to a patients’ heart muscle (called ischemia), and it is
used by the interventional cardiologist to direct coronary
interventions and assess results for improved treatment
outcomes.
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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St. Jude Medical, Inc.J.C. Weigelt, 651-756-4347Investor
Relationsjweigelt@sjm.comorLaurel Hood, 651-756-2853Media
RelationsLHood02@sjm.com
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