Blood flow blockages in heart measured using wireless fractional
flow reserve technology
13 October 2009
St Jude Medical, Inc. (NYSE: STJ) has announced the first use of the
PressureWire Aeris technology, an interventional tool which measures
Fractional Flow Reserve (FFR) to evaluate the severity of blood flow
blockages in the arteries.
The new diagnostic tool combines St Jude Medical’s PressureWire Aeris
with GE’s Mac-Lab Hemodynamic Recording System. The technology helps
interventional cardiologists better determine the ideal treatment option
for their patients during coronary interventions, such as stent
The first procedures in the US were performed by Dr Mark Zolnick at
CHRISTUS St Vincent Regional Medical Center in Santa Fe, New Mexico.
The PressureWire Aeris is a first-of-its-kind wireless FFR system
which requires no additional equipment or cabling in the cardiac
catheterization laboratory. Using the PressureWire Aeris technology,
interventional cardiologists can accurately assess the severity of
Having this information available prior to placement of coronary
stents helps physicians better determine which specific lesion or
lesions are responsible for a patient’s ischemia, a deficiency of blood
supply to the heart caused by blood restriction.
“Using the PressureWire Aeris helped me determine instantly and with
certainty the best course of treatment for my patients. In the first
case, I was able to decide that the narrowing of the arteries wasn’t
severe enough to warrant stenting, and in the next I used the FFR
technology to confirm the ideal stent placement,” said Dr. Mark Zolnick,
a cardiologist at New Mexico Heart Institute.
“The PressureWire Aeris is extremely easy to use, reduces material
costs and improves patient outcomes. From both a clinical and cost
effectiveness perspective, I believe that this technology should be a
standard of care.”
The landmark FAME trial, which compared FFR-guided treatment using
St. Jude Medical PressureWire technology to stenting with angiography
alone, found that in addition to saving about 11% in unnecessary
material cost, instances of major adverse cardiovascular events, such as
death, myocardial infarction and repeat revascularization, are reduced
by 28%. The study also found that routine measurement of FFR requires no
additional procedure time.
“St. Jude Medical is focused on providing physicians with
technologies that aid them in making the best treatment decisions for
their patients,” said Frank Callaghan, president of St. Jude Medical’s
Cardiovascular Division. “PressureWire Aeris guides physicians to more
accurately diagnose and treat their patients, significantly improving
patient outcomes. Procedural set-up and workflow are also now improved,
and having FFR measurements immediately accessible on existing cath lab
instrumentation allows for quicker integration with patient records and
a lower barrier to entry for the hospital to implement this
The PressureWire Aeris system integrates FFR technology directly into
the Mac-Lab Hemodynamic Recording System to immediately display, measure
and save FFR data. With FFR results integrated into a patient’s existing
study record, this is the only system on the market where the severity
of coronary lesions is documented together with other procedural data
and angiographic imagery.
The Mac-Lab FFR upgrade, which is available for the XT and XTi
Mac-Lab configurations, combines existing catheterization lab
infrastructure, including screens, input modules and controls, with the
PressureWire Aeris technology to form a seamlessly integrated FFR
measurement system, resulting in improved workflow.
The wireless technology of the PressureWire Aeris also eliminates
cables crossing the sterile field, reducing variables and making the
entire procedure faster and easier. Physicians can remove the device’s
handle and insert a stent delivery system directly over the PressureWire
Aeris, eliminating the time and cost of using an additional, traditional
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. 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.
The landmark trial FAME (Fractional flow reserve (FFR) vs.
Angiography in Multivessel Evaluation), which used St. Jude Medical
PressureWire technology, was published in the Jan. 15, 2009 issue of the
New England Journal of Medicine.
It demonstrated a statistically significant difference of 28% in
Major Adverse Cardiac Events (MACE) such as death, myocardial infarction
and repeat revascularization. The randomized, prospective, multi-center
trial looked at 1,005 patients with multi-vessel coronary artery disease
12 months after receiving a stent, and compared outcomes for patients
whose treatment was guided by FFR to those whose treatment was guided
only by angiography.
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