By Business Wire, March 11, 2013, 08:00:00 AM EDT
Japan is the first market to offer the next-generation FFR and OCT
ILUMIEN OPTIS System for stent placement
ST. PAUL, Minn.--(BUSINESS WIRE)--
St. Jude Medical, Inc. (NYSE:STJ), a global medical device company,
today announced the launch of its ILUMIEN™ OPTIS™
System, a next-generation technology designed to help physicians make
personalized stenting decisions based on each patient's unique anatomy
and disease state. The new ILUMIEN OPTIS system remains the only
combined Fractional Flow Reserve (FFR) and intravascular Optical
Coherence Tomography (OCT) imaging technology platform. Together, FFR
and OCT offer physicians a physiological and anatomical view of the
coronary vessels to help diagnose and treat coronary artery disease. The
ILUMIEN OPTIS system provides enhancements to the ILUMIEN™
System, including a first-of-its-kind stent planning software tool.
"The ILUMIEN OPTIS system enables a higher image resolution, and thus
makes it possible for us to analyze difficult anatomical structures,
allowing me to focus on diagnostic and treatment strategies. Also, this
new analytical tool will be helpful for sizing and placing the stent.
This technology has become increasingly important to help efficiently
diagnose and treat patients," says Dr. Takashi Akasaka of Wakayama
Medical University.
The PressureWire™
Aeris™ Wireless FFR Measurement System collects detailed
analyses of blood flow blockages in the coronary vessels to help
determine which specific blockages are causing the patient's blood flow
to be ineffective. The FFR pressure guidewire is directed through the
coronary arteries and across the narrowed vessel, taking measurements as
the guidewire is pulled back through the narrowed part of the artery.
The OCT technology in the new ILUMIEN OPTIS system uses the Dragonfly™
JP Imaging Catheter to capture near-infrared light imaging and
measureimportant vessel characteristics otherwise invisible or
difficult to assess with older intracoronary imaging tools. New high
resolution setting and real-time, three-dimensional (3-D) reconstruction
with the ILUMIEN OPTIS provide a 360-degree panoramic view of the
vessel, which makes it easier for physicians to visualize the anatomy
they are treating.
The FFR and OCT measurements captured by the ILUMIEN OPTIS system allow
physicians to more easily differentiate plaque build-up and determine if
the narrowed arteries are causing ischemia, or a restriction in blood
flow, ultimately assisting in stent placement. Three-Dimensional
representation enables better visualization in preparation for stenting
and evaluation of the stent's position once placed. These advanced
functionalities have previously only been available off-line.
Three-Dimensional vessel reconstruction offers a better picture, and
real-time analysis streamlines workflow, potentially helping physicians
diagnose their patients more quickly.
"We are very pleased to offer the ILUMIEN OPTIS system in Japan, which
is a world leader in imaging technology utilization," said William
Phillips, president of St. Jude Medical Japan. "The new system is the
latest in PCI optimization technology, and helps physicians understand
the needs of each patient, ultimately resulting in better medical
decision making and overall cost-effective treatment."
The benefits of FFR have been supported in a number of clinical trials,
including FAME
and FAME
2. The trials effectively demonstrate the important role FFR plays
in improving patient care. Results from the original FAME trial found
that instances of major adverse cardiovascular events (MACE) were
reduced in patients whose treatment was guided by FFR rather than by
standard angiography alone. The FAME 2 study revealed the number of
patients returning to the hospital for urgent care was 86 percent lower
for patients with stable coronary artery disease whose stenting
procedure was guided by FFR than for those who received medical therapy
alone.
Each year in Japan about 245,000 Percutaneous Coronary Intervention
(PCI) procedures are performed to treat cardiovascular disease, and of
those, nearly 80 percent are estimated to use imaging technology.
ILUMIEN OPTIS comes with both English and Japanese language options.
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.
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Source: St. Jude Medical, Inc.