|
St. Jude Medical Continues Strong Show of PCI Optimization Technologies at EuroPCR
New technology, symposia and a FAME II data presentation keep St. Jude Medical at the forefront of PCI Optimization
|
 |
St. Jude Medical's PressureWire with agile tip |
May 14, 2012 -- St. Paul, Minn and Paris --
St. Jude Medical, Inc., a global medical device company,
today announced it will display a number of technologies from the
company's wide array of clinical solutions and launch its
next-generation PressureWire Fractional Flow Reserve (FFR)
assessment guidewire at EuroPCR 2012. There will also be a number of
St.
Jude Medical
-sponsored percutaneous coronary intervention (PCI)
optimization symposia and a late-breaking clinical trial session on the
FAME II trial.
"With the launch of ILUMIEN, and the ongoing research about our
PressureWire technologies from the FAME family of trials, St. Jude
Medical's PCI optimization technologies have been some of the most
talked about at EuroPCR over the past several years, and this year will
be no exception," said Frank J. Callaghan, president of the St. Jude
Medical Cardiovascular Division. "Our focus on improving patient care
and reducing health care costs is unrelenting, which is why we're
continually supporting research to learn more about clinical and
economic benefits of our PressureWire FFR measurement technology."
FAME II Late-Breaking Trial Session
The late-breaking clinical trial session revealing new data from the
FAME II clinical study will take place on
Tuesday, May 15
, from 15:00
17:25 in the main arena. Investigators will present the study design, a
subset of primary endpoint data, and discuss how the study results may
change physicians' practice.
The goal of the
St. Jude Medical
-sponsored FAME II (Fractional Flow
Reserve Guided Percutaneous Coronary Intervention Plus Optimal Medical
Treatment vs. Optimal Medical Treatment (OMT) Alone in Patients with
Stable Coronary Artery Disease) trial is to study the role of FFR in the
treatment of stable coronary artery disease by comparing PCI guided by
FFR plus OMT to OMT alone. Enrollment in the trial was stopped following
a recommendation from the Data Safety Monitoring Board (DSMB) after they
found a highly significant reduction in the need for hospital
readmission and urgent revascularization when FFR-guided assessment was
used to direct treatment. The DSMB considered it unethical to continue
to randomize patients to OMT alone.
FFR measurement identifies the severity of narrowings in the coronary
arteries and allows for a more effective assessment of coronary lesions,
or blockages, resulting in more accurate diagnosis and improved
appropriate treatment of coronary artery blockages.
PressureWire with Agile Tip Launch
St. Jude Medical
is announcing the European launch of its latest FFR
assessment technology, the PressureWire with Agile Tip. The
next-generation of PressureWire was designed to replicate the
performance of standard PCI guidewires and deliver exceptional handling
even in the most challenging anatomies. Available in both the Aeris
(wireless) and Certus PressureWire models, the guidewire can also
deliver interventional tools more easily, for faster and more
cost-effective PCI.
"The new PressureWire platform offers exceptionally easy-to-use
technology and allows me to assess my patients' coronary arteries more
quickly and accurately," said Lars Hellsten, MD, Senior
Interventionalist,
PCI Cath Lab
at Gδvle Hospital,
Sweden
. "I am
extremely pleased with the usability and added sense of control I get
with St. Jude Medical's latest FFR technology."
The next-generation PressureWire features symmetrical Agile Tip
technology, which greatly improves steerability in tortuous anatomies,
and a new proprietary hydrophilic coating that reduces friction,
allowing for easier deployment of stents and coronary balloons.
St. Jude Medical Sponsored Symposia:
St. Jude Medical
will sponsor two sessions focusing on PCI Optimization:
-
FAME-trials Family: Physiology, Decision-making and Clinical
Outcomes Symposium,
Tuesday, May 15
, 17:0018:30 in room 252AB.
-
Optimizing PCI and Patient Outcomes with Combined FFR and OCT
Guidance,
Thursday, May 17
, 12:0014:00 in the Theatre Bordeaux.
Attendees can visit
St. Jude Medical
at booth F8 and F9 found on Level 1
of the exhibition hall during EuroPCR to see ILUMIEN the first
combined FFR and OCT system, PressureWire with Agile Tip and other
leading technologies.
EuroPCR is the official congress of the
European Association of
Percutaneous Cardiovascular Interventions
(EAPCI), a leading
international course for interventional cardiovascular specialists.
About
St. Jude Medical
St. Jude Medical
develops medical technology and services that focus on
putting more control into the hands of those who treat cardiac,
neurological and chronic pain patients worldwide. The company is
dedicated to advancing the practice of medicine by reducing risk
wherever possible and contributing to successful outcomes for every
patient.
St. Jude Medical
is headquartered in
St. Paul, Minn.
and has
four major focus areas that include: cardiac rhythm management, atrial
fibrillation, cardiovascular and neuromodulation. For more information,
please visit sjm.com.
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 31, 2011
and Quarterly Report on
Form 10-Q for the fiscal quarter ended
March 31, 2012
. The Company does
not intend to update these statements and undertakes no duty to any
person to provide any such update under any circumstance.
Source:
St. Jude Medical, Inc.
|
