LEIPZIG, Germany, Jan. 26, 2011 /PRNewswire/ — 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
months.
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
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