St. Jude Medical Expands Hospital Access to Wireless Fractional Flow Reserve Technology with New Agreement
November 08 2011 - 11:17AM
Business Wire
St. Jude Medical, Inc. (NYSE: STJ), a global medical device
company, today announced its wireless PressureWire™ Aeris
technology, which aids in the diagnosis and treatment of coronary
artery blockages by measuring Fractional Flow Reserve (FFR), will
now be available to hospitals using the Philips Xper Flex Cardio
physiomonitoring system. Physicians will have greater access to the
market’s only wireless FFR measurement system through this new
Philips agreement.
FFR measurements indicate the severity of blood flow blockages
in the coronary arteries, allowing physicians to better identify
which specific lesion or lesions are responsible for a patient’s
ischemia, a deficiency of blood supply to the heart caused by blood
flow restriction. The PressureWire Aeris technology helps
physicians determine the best treatment options for patients during
coronary interventions, such as stent procedures.
The PressureWire Aeris system offers a secure, wireless
interface between PressureWire and a cath lab’s hemodynamic
recording system to immediately display, measure and save FFR data.
With FFR results integrated into a patient’s existing study record,
the severity of coronary lesions is documented together with other
procedural data and angiographic imagery. The wireless technology
of the PressureWire Aeris also eliminates cables crossing the
sterile field, reducing risk of contamination, and making the
entire procedure faster and easier.
The Philips Xper Flex Cardio physiomonitoring system has been
designed to streamline the overall workflow of the entire
catheterization suite. A single interface on the Philips
physiomonitoring system combines both the FFR measurement controls
and clinical documentation including lesion, stage and medication.
This unique integration between the PressureWire Aeris wireless
technology and the Philips physiomonitoring system provides
availability of this important clinical data in the physician
reporting module. The new product line offers a truly integrated
wireless FFR solution for physicians.
Two-year follow-up data from the landmark FAME (Fractional flow reserve (FFR) vs. Angiography in Multivessel Evaluation) trial compared FFR-guided treatment
using a St. Jude Medical PressureWire to treatment using standard
angiography alone, and found both superior clinical outcomes and
reduced healthcare costs in patients whose treatment was based on
FFR. The combined risk of death or myocardial infarction (heart
attack) was 34 percent lower for patients whose treatment was
guided by PressureWire technology prior to coronary stenting.
FFR-guided treatment using the St. Jude Medical PressureWire
System was also found by the FAME trial to be cost-saving, with a
difference of about $2,000, or a 14 percent reduction in health
care costs to the hospital between the two patient groups after one
year. These lower health care costs were a result of reduced
procedural costs, reduced follow-up costs for major adverse cardiac
events and shorter hospital stays.
“St. Jude Medical’s FFR technology is clinically proven to
significantly improve patient outcomes while reducing costs to the
health care system,” said Frank Callaghan, president of the St.
Jude Medical Cardiovascular Division. “This agreement with Philips
allows physicians to more easily gain access to the only wireless
FFR measurement system available.”
Because of this new agreement with Philips, and existing
compatibility with other recording systems including the GE
Mac-Lab(R) Hemodynamic Recording System, Mennen Horizon XVu,
McKesson Horizon Cardiology Hemo(TM) solution and Siemens AXIOM
Sensis XP, the PressureWire Aeris technology can be used in nearly
all cardiac cath labs for wireless integrated FFR measurement
utilizing existing hardware.
About Fractional Flow Reserve (FFR)
Fractional Flow Reserve (FFR) is an index determining the
functional severity of narrowings in the coronary arteries. 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 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
January 1, 2011 and Quarterly Report on Form 10-Q for the fiscal
quarter ended July 2, 2011. 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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