Long Lesion Study Demonstrates SUPERA(R) Stent Efficacy in SFA and Popliteal Arteries
By Idev Technologies Incorporated, PRNEMonday, May 16, 2011
SUPERA Shows Remarkable Patency in Difficult Lesions
NOORDWIJKERHOUT, Netherlands and WEBSTER, Texas, May 17, 2011 - IDEV Technologies announced today that data from a long lesion study of
182 patients with significantly diseased superficial femoral arteries and
popliteal arteries showed high patency rates and no stent fractures after
treatment with the SUPERA VERITAS(R) Peripheral Vascular Stent System. The
data were presented at the Vaatdagen 2011 (Vascular Days) Conference based on
analysis by Andre Molenaar, M.D. and Peter Haarbrink, M.D., interventional
radiologists at Canisius-Wilhelmina Ziekenhuis (CWZ) hospital, a leading
teaching and high volume medical center in Nijmegen, Netherlands.
The patients were treated and followed over a two year period, and
represented an extremely challenging patient cohort with highly calcified and
long lesions in the superficial femoral artery (SFA) which at times
encompassed the proximal popliteal artery and/or popliteal artery alone. What
makes these results extraordinary was that they were achieved in vessels with
significant disease and atypical extremely long lesion lengths with no
Plavix(R) used.
The SFA plus proximal popliteal treated artery cohort consisted of 159
patients, with an average lesion length of 240mm, 40% Tasc D classification,
and 57% total occlusions with an average of nearly 2 stents per patient. A
high patency rate of 74% was achieved at 12 months as measured by Duplex
Ultrasound (DU). A group of 23 patients were treated with a SUPERA stent in
the popliteal artery, with an average stent length of 142mm and a patency
rate of 83% at 12 months, again measured by DU. A subgroup analysis by x-ray
at 24 months showed no stent fractures. These data compare favorably to
standard nitinol stent performance in patients with significantly shorter
lesions.
"These are outstanding and noteworthy results which demonstrate that
SUPERA is a market changing technology when used appropriately," stated Dr.
Molenaar. "The average stent length deployed was 240mm, ranging from 40mm to
550mm. Compared with other stent trials, and even the Leipzig SUPERA
registry, these are much longer lesions with significant disease," added Dr.
Haarbrink.
Dr. Molenaar added that no concomitant treatment occurred with
antiplatelet medication. "Patients received aspirin post procedure but none
of these patients received Plavix(R) following their stent procedures. We can
assume the results would have had an even more dramatic improvement from
baseline had we supplemented our procedure with this treatment. It is also
clear to us that we utilize SUPERA for the most challenging cases, constantly
testing the device and still receive exceptional results. We look forward to
continuing our analysis of SUPERA."
Christopher M. Owens, President and CEO of IDEV Technologies, Inc.,
commented, "We are pleased to see clinicians continue to independently
evaluate the SUPERA stent in highly diseased patients. These extremely
positive results reflect what we see on a continual basis in the
marketplace."
About Canisius-Wilhelmina Ziekenhuis (CWZ)
CWZ is one of the top clinical training hospitals in the Netherlands,
with over 650 beds and 31 medical specialties. For more information please
visit www.cwz.nl.
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,
Texas 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 Europe,
Canada and Australia for the treatment of biliary strictures produced by
malignant neoplasms and for peripheral vascular use following failed
percutaneous transluminal angioplasty (PTA).
Contact: Donna Lucchesi Vice President Global Marketing IDEV Technologies, Incorporated +1-281-525-2000
.
Tags: Idev Technologies Incorporated, May 17, Netherlands, Netherlands And Webster, Noordwijkerhout, texas