Long-Term European Data Released for SUPERA(R) Stent from IDEV Technologies

By Idev Technologies Incorporated, PRNE
Tuesday, January 25, 2011

Impressive Two-Year Patency Results Reported for SFA Procedures, with Zero Stent Fractures

LEIPZIG, Germany, January 26, 2011 - IDEV Technologies, Incorporated (IDEV), an innovative leader in the
development and commercialization of minimally invasive medical technologies,
today announced the release of two-year European data from the prominent
Leipzig Registry, which tracks patients treated with the SUPERA wire
interwoven nitinol stent. The SUPERA stent is CE marked for biliary and
peripheral vascular use in Europe. In the United States, the SUPERA stent is
currently being studied in an ongoing FDA approved IDE trial for treatment of
peripheral arterial disease of the superficial femoral artery (SFA).

The single-center registry includes data from 107 patients treated for
peripheral arterial disease of the SFA. Within the study population, about a
third of the patients had occlusions, 17 percent were categorized as
Rutherford 4 or 5, and another 82 percent were Rutherford 3. Additionally,
half the treated lesions required placement of the SUPERA stent in the distal
third of the SFA. These highly diseased patients, with severely calcified
lesions, had an average treated lesion length of approximately 11
centimeters, nearly double that in other stent trials.

Results were presented by Sven Braunlich, MD of the Department of
Angiology at Park Hospital and Heart Center, Leipzig, Germany during the 2011
Leipzig Interventional Course (LINC). Key data points include a primary
patency rate of 76 percent by duplex ultrasonography at two years with no
stent fractures. The 12-month patency rate was 85 percent, and the 18-month
patency rate was also 76 percent, showing stable patency from 18 to 24

Dr. Braunlich remarked, "The SUPERA stent has been shown in independent
testing to be extremely crush and fracture resistant compared to standard
nitinol stents. Combined with the flexibility of the interwoven design, it is
very well suited for use in the challenging SFA. X-ray screening, conducted
at an average follow-up of 17 months, documented excellent durability of the
SUPERA stent in the SFA, detecting zero fractures. In addition, there was
statistically significant improvement in ABI (ankle brachial index) and
Rutherford scores at all follow-up time points. These represent important
clinical benefits to patients, and may translate into fewer repeat

Kenneth Rosenfield, MD and Director of Cardiac and Vascular Invasive
Services at Massachusetts General Hospital in Boston, is co-principal
investigator of the IDE trial and was also on faculty at this year's LINC.
"The ongoing work at Leipzig, and the promising patency data reported in the
Registry, helped establish the basis for the U.S. SFA trial. We are
encouraged by the Registry results, and look forward to completing enrollment
in the SUPERB clinical trial in the first half of 2011," Rosenfield said.

"These latest data demonstrate that the SUPERA stent provides an
excellent option for treating patients with peripheral arterial disease in
the femoral-popliteal arteries, and may represent a paradigm shift in how
these patients are treated," commented M. Laiq Raja, MD of El Paso Cardiology
Associates, P.A. and Providence Memorial Hospital in El Paso, Texas. He
reviewed the long term data while attending LINC and added, "I am very
impressed to see the zero percent fracture rate, and look forward to seeing
the publication of these results later this year."

Eric Dippel, MD, of Cardiovascular Medicine, P.C. at Trinity Regional
Health System in Davenport, Iowa observed during LINC, "This is the longest
follow-up data available for a novel stent that shows sustained excellent
results. I am very impressed with the durability in the 18- to 24-month

Christopher Owens, President and CEO of IDEV, said, "These patency
results are outstanding. The fact that patency scores are remaining at this
level over an extended period reflect the unsurpassed durability, strength
and flexibility of the SUPERA stent, and reinforces that it truly represents
a different class of stent. We are excited about our expansion opportunities
in Europe given the acceptance of these data and our market changing

The independent testing referenced by Dr. Braunlich reported zero stent
fractures for any SUPERA stent tested after 10 million cycles of 120 degree
flexion and extension and 20 million cycles of torsion. Additionally,
compression testing demonstrated a minimum of four times the radial strength
and 360 percent stronger crush resistance than standard nitinol stents.
Throughout this testing, the SUPERA stent completely resisted fracturing,
kinking, crushing, and crimping. In comparison, all standard nitinol tubular
stents tested fractured before 100 thousand cycles in the flexion and
extension testing and before 1 million cycles in the compression load

About IDEV Technologies, Incorporated

IDEV Technologies, Incorporated (IDEV) is an innovator and developer of
next generation medical devices for use in interventional radiology, vascular
surgery and cardiology. IDEV's worldwide headquarters is located in Webster,
and its European headquarters is located in Beuningen, The Netherlands.
For more information please visit www.idevmd.com.

The SUPERA stent is currently indicated in the U.S. for the palliative
treatment of biliary strictures produced by malignant neoplasms and in Europe
for the treatment of biliary strictures produced by malignant neoplasms and
for peripheral vascular use following failed percutaneous transluminal
angioplasty (PTA).

About the Leipzig Interventional Course (LINC)

The Leipzig Interventional Course is committed to advancing the
scientific and clinical evaluation and treatment of patients with complex
vascular disease through an interdisciplinary discussion of novel
endovascular techniques. For more information please visit

    Contact: Donna Lucchesi
             Vice President Global Marketing
             IDEV Technologies, Incorporated

Donna Lucchesi, Vice President Global Marketing of IDEV Technologies, Incorporated, +1-281-525-2000

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