QUEBEC CITY, Feb. 23 /CNW Telbec/ - Opsens Inc. (TSXV: OPS) ("Opsens")
said today that its Medical Division has reached a significant
milestone, successfully completing a pre-clinical animal study on the
EasyWire device, designed to measure Fractional Flow Reserve in the
evaluation of coronary lesions.
Fractional flow reserve (FFR) is an index of the functional severity of
coronary stenoses calculated from pressure measurements taken before
and after a narrowing of arteries discovered during coronary
angiography. This approach is gaining momentum in interventional
cardiology catheterization laboratories because it more precisely
determines if lesions are causing myocardial ischemia (lack of oxygen to the heart muscle). If the FFR test is positive, an
interventional cardiologist can discuss treatment options directly with
the patient, either angioplasty to install a stent or by-pass surgery
if there are multiple lesions. FFR also reduces the number of non
invasive testing before performing diagnostic angiography.
Results of "Fractional Flow Reserve vs. Angiography for Multivessel
Evaluation", the so-called FAME study, a landmark multi-center study
published in the New England Journal of Medicine in 2009, found that
patients subjected to FFR had fewer stents used and better outcomes
overall compared with patients evaluated with angiography only. A
further FFR study published in December 2010's Circulation builds on
those findings by saying this "is one of those rare situations in which
a new technology not only improves outcomes but also saves resources."
EasyWire and OptoWire for the measurement of FFR
Technically, existing FFR guide wires cannot evaluate all types of
lesions. The EasyWire is a miniature catheter instrumented with a fiber
optic sensor that slides over most existing 0.014" guide wires. The
EasyWire provides a no-drift, highly accurate and reliable measurement
of pressure in coronary arteries, and gives cardiologists, in
opposition to existing guide wires, the freedom to use their favourite
guide wire by simply slipping on the catheter tip.
The OptoWire is a guide wire instrumented with a fiber optic pressure
sensor which is drift free, and provides a high fidelity measurement of
blood pressure in coronary arteries. In addition to more reliable
measurement, the OptoWire offers better mechanical performance in terms
of trackability, torquability and support over other existing pressure
With the EasyWire and the OptoWire, Opsens will offer cardiologists
specialized in hemodynamics a highly stable and reliable technology to
evaluate all types of coronary lesions to discuss best treatment
options with the patient as the exam is being performed.
Pre-clinical results on the EasyWire
Data from the animal study showed that the EasyWire is safe, delivers
good trackability (ability to advance the device through the artery to
reach all types of lesions), and that the pressure measurements taken
during the study were optimal. The EasyWire performed exceptionally
well, with benefits believed to answer to some important unmet needs.
The animal study was performed at Institut universitaire de cardiologie
et de Pneumologie de Québec (Quebec heart and lungs institute) by Dr.
Olivier Bertrand, a cardiologist specialized in hemodynamics,
researcher for Quebec's funded research centre (FRSQ) and professor at
the Faculty of Medicine, Université Laval.
"Compared with products available on the market, I found the EasyWire
very practical, allowing for a very reliable measurement of intra
coronary pressures. In addition, having the possibility to use our
usual angiography guide wires is a considerable advantage to reach
difficult lesions," said Dr. Bertrand. "I was also impressed by the
technical qualities of the OptoWire" he added.
Opsens portfolio for the measurement of FFR
"Recent strong favourable outcomes data related to the use of FFR to
guide PCI (Percutaneous Coronary Intervention) have brought new
interest in using a pressure wire for coronary lesion assessment," said
Dr. Morton Kern, University of California, Irvine, Cardiology and
Chairman of Opsens' scientific advisory board. "Opsens' new pressure
wire systems, both pressure wire and microtransit pressure monorail
(EasyWire) appear to provide high-quality pressure tracings comparable
to available systems, and will permit broader applications to the use
of FFR for patient care."
"Strong evidence continues to build in favour of the practice of FFR,
calling for more efficient tools to perform the exam. Opsens is putting
together a complete tool box for cardiologists to use in the
measurement of FFR, allowing them to select the tool better adapted to
a specific case," said Claude Belleville, VP Medical. "The OptoWire and
EasyWire are complementary products: a cardiologist may choose the
OptoWire for a diffused lesion or easy-to-reach lesions, while the
EasyWire may be better suited for lesions that are more difficult to
Opsens' in-house medical research team developed the EasyWire over the
last two years, and is being supported through the clinical study and
commercialization stages by its scientific advisory board composed of
Dr. Bertrand, Dr. Kern and Dr. Michael J. Lim, all cardiologists
recognized for their expertise and knowledge in the field of FFR.
Based on these very good results, Opsens intends to pursue a complete
plan that will bring the EasyWire and the OptoWire to the market by
About Opsens (www.opsens.com)
Opsens is a leading developer, manufacturer and supplier of a wide range
of fiber optic sensors and associated signal conditioners based on
proprietary patented and patent pending technologies. Opsens' sensors
provide long-term accuracy and reliability in the harshest
environments. Opsens provides sensors to measure pressure, temperature,
strain and displacement to original equipment manufacturers (OEM) and
end-users in the oil and gas, medical and laboratory fields. Opsens
provides complete technical support, including installation, training,
after-sales service, for its fiber optics systems that are regulated by
the ISO 9001-2008 norm.
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that term is defined in the policies of the TSX Venture Exchange)
accepts responsibility for the adequacy or accuracy of this release.
Forward-looking statements contained in this press release involve known
and unknown risks, uncertainties and other factors that may cause
actual results, performance and achievements of Opsens to be materially
different from any future results, performance or achievements
expressed or implied by the said forward-looking statements.
SOURCE OPSENS INC.
For further information:
Pierre Carrier, President and Chief Executive Officer, 418.682.9996
Louis Laflamme, CA, Chief Financial Officer, 418.682.9996