SMT Research and Development, Ltd. Reports Two Successful Clinical Cases

February 9, 2010

HERZLIYA PITUACH, Israel, February 9 /PRNewswire/ — SMT Research and
Development, Ltd., a privately held company, announced that it has completed
its first two clinical cases using the Shimon Embolic Filter [SHEF] (TM). SMT
R&D developed a novel technology for brain protection (Neuroprotection) from
stroke complication hazards arising from invasive cardiology procedures and
heart surgery. The rate of stroke and silent brain damage is the leading
severe limiting factor for delivering the trans-catheter and invasive
therapeutic modalities. Neuroprotection from stroke and brain emboli is a
largely untapped major field. The SHEF filter reduces significantly the risk
of emboli (blood clots and other debris) from traveling to the brain. The
procedure was performed at the University Medical Center, Utrecht, The
by Dr. Pieter Stella, Director of Cardiac Catheterization and
Interventional Cardiology.

The SMT filter is a proprietary medical device that acts as a filter,
allowing normal blood flow to the brain, but filtering and diverting all
emboli (blood clot, atheromatous material and calcified debris) downstream,
thus preventing stroke. The product is designed to be used during
interventional and surgical procedures, remaining in the patient throughout
the procedure, and optionally for 24 hours, The device has a curved “snow
shoe” design, with opposite stabilizers to fully fixate the device in the
aortic arch. The filter is introduced in minutes through an arterial puncture
and removed in the same mode. SMT R&D was established in November 2004 and is
located in Herzliya, Israel. The SMT Filter device was used in a 57-year-old
female patient, and a 54-year-old male patient. Both underwent repeated PCI
(percutaneous coronary intervention) for treatment of instent restenosis
(re-narrowing within a coronary stent). The patients had high risks of stroke
complication due to paroxysmal rhythm disturbance. Rhythm disturbances
increase the risk of clot formation within the left side of the heart, mainly
in the left atrial appendage. These clots may dislodge and travel to the
brain via the blood stream. “It is an exciting beginning of a new era for
Neuroprotection. We are pleased with the overall success and ease of
implementation of the SMT filter,” said Dr. Dov Shimon MD, Founder and CEO,
SMT Research and Development, Ltd. “

The SMT filter device was inserted through the right common femoral
artery, and passed retrograde through the descending aorta and positioned
along the aortic arch, in front of all arterial branches to the brain. The
device maintained its position throughout the test. Subsequent passage of
angiographic catheters and dye injection did not affect the position of the
filter. “We were very pleased to see how easy and uneventful the procedures
were.” The design and engineering are user-friendly and intuitive for the
cardiologist. The filter covered all the aortic arch, preventing the
possibility of embolic stroke. For me and my colleagues, this is as an
important adjunct as valve repairs, valve replacements and other structural
heart problems that are currently treated and new modalities for treatment
which are rapidly being developed. Moreover, this population of patients is
sicker and increasingly older, thus the safety of the brain becomes a major
issue,” commented Dr. Pieter Stella.

“This is a significant milestone for SMT R&D. The engineering and
scientific teams worked for 4 years to bring the filter to the clinic. It is
easy and safe and to use, and is likely to provide optimum protection from
stroke. These are the first and second clinical cases using our aortic
embolic protection device designed for interventional procedures. A
feasibility study is underway in Europe, in The Netherlands and Germany, to
be followed in other countries, added Dr. Dov Shimon.

*The Shimon Embolic Filter [SHEF] (TM) device is not yet available for
clinical use in the United States.

    For more information, contact:

    Dr. Dov V. Shimon
    M.D. - CEO, SMT R&D Ltd.
    T: +972-9-950-8089
    F: +972-9-950-8103


SOURCE SMT Research and Development Limited

Source: newswire

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