ST. PAUL, Minn.–(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.
