New Agreement with Siemens Further Expands Access to the Company's Wireless PressureWire Aeris Fractional Flow Reserve Measurement Technology Recently Launched Next-Generation PressureWire Certus Offers Enhanced Handling Capabilities with More Control for PhysiciansST. PAUL, Minn., Mar 15, 2010 (BUSINESS WIRE) -- St. Jude Medical, Inc. (NYSE: STJ), a global medical device company,
announced several updates to its PressureWire(TM) platform, including a new
marketing agreement with Siemens Medical Solutions USA, for the wireless
PressureWire(TM) Aeris and the availability of the next-generation of
PressureWire(TM) Certus technology, at the American College of Cardiology
(ACC) and the Society of Interventional Radiology (SIR) annual meetings.
The enhanced capabilities make the company's leading Fractional Flow
Reserve (FFR) measurement technology, which aids in the diagnosis and
treatment of coronary artery blockages, more versatile and accessible
for physicians around the world.
The PressureWire Aeris and Certus provide FFR measurements, which
indicate the severity of blood flow blockages in the coronary arteries.
This physiological measurement helps 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 restriction.
"The PressureWire segment is one of the biggest areas of growth for St.
Jude Medical's interventional business because of its clinical benefits
and ability to reduce the cost of PCI procedures," said Frank Callaghan,
president of St. Jude Medical's Cardiovascular Division. "We continue to
invest in PressureWire technology to improve its ease-of-use and to help
establish FFR measurement as a standard of care across a broader range
PressureWire Aeris Agreements:
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 variables
and making the entire procedure faster and easier.
St. Jude Medical's new agreement with Siemens will enable integrated
wireless FFR measurement with PressureWire Aeris as an upgrade to
hospitals using the Siemens AXIOM Sensis XP. The AXIOM Sensis XP is one
of the most widely used hemodynamic recording systems in cath labs and
offers advanced measurement programs which aid physicians in
Because of this new agreement with Siemens, and existing compatibility
with other recording systems including the GE Mac-Lab(R) Hemodynamic
Recording System, Mennen Horizon XVu and the McKesson Horizon Cardiology
Hemo(TM) solution, the PressureWire Aeris technology can be used in the
majority of cardiac cath labs for wireless integrated FFR measurement
utilizing existing hardware.
Next-Generation PressureWire Certus:
The new PressureWire Certus includes modifications to design and
functionality which will provide physicians with more controlled
handling and versatility. It is the only guidewire on the market to
offer in one wire the combined measurement of pressure and temperature
which enables calculations of FFR, Coronary Flow Reserve (CFR) and an
Index of Microcirculatory Resistance (IMR).
The PressureWire Certus was the only FFR measurement system used in the
landmark FAME (Fractional Flow
Reserve (FFR) vs. Angiography in Multivessel
Evaluation) trial, which found
both superior clinical outcomes and reduced healthcare costs in patients
whose treatment was based on FFR.
Recently presented two-year follow-up data from the landmark FAME trial
demonstrated that the combined risk of death or myocardial infarction
(heart attack) was 34% lower for patients whose treatment was guided by
PressureWire technology prior to coronary stenting. Additionally, FFR
measurement did not increase the procedural time.
FFR-guided treatment using the PressureWire system was also found to
save healthcare costs, with a difference of about $2,000, or 14%, in
reduced costs between the two patient groups after one year. These lower
healthcare costs were a result of reduced procedural costs, reduced
follow-up costs for major adverse cardiac events and shorter hospital
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 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 guides the
interventional cardiologist in assessing which lesions warrant coronary
interventions which results in 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.
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, 2010. 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.
St. Jude Medical, Inc.
Angie Craig, 651-756-2191
Marisa Bluestone, 651-756-6739