One-Year European Registry Data Released for Popliteal Stenting With SUPERA(R)By Idev Technologies Incorporated, PRNE
Monday, February 7, 2011
Zero Fractures and Impressive Patency Results Reported for Unique Stent from IDEV Technologies
LEIPZIG, Germany, February 8, 2011 - Data from the Leipzig Registry tracking the results of patients treated
with the SUPERA(R) stent for peripheral arterial disease (PAD) of the
popliteal artery were reported during the recent 2011 Leipzig Interventional
Course (LINC). The SUPERA stent is CE marked for biliary and peripheral
vascular use in Europe. In the United States the SUPERA stent is the subject
of an ongoing FDA-approved IDE trial called SUPERB (Comparison of the SUPERA
PERipheral System to a Performance Goal Derived from Balloon Angioplasty
Clinical Trials in the Superficial Femoral Artery) for treatment of PAD of
the superficial femoral artery (SFA).
Dr. Andrej Schmidt of the Department of Angiology at Park Hospital and
Heart Center in Leipzig presented the 12-month European data. The 101
patients treated at Park Hospital had advanced PAD. Nearly a third of the
patients were classified as Rutherford 4 or 5, and almost 50 percent had an
occlusion of the popliteal artery. The average stent length within the
registry was approximately 8.5 centimeters.
The primary patency rate, measured by duplex ultrasonography, was 87
percent at 12 months. In addition, there were no stent fractures detected by
x-ray at an average of 13.3 months.
"The SUPERA stent has become our stent of choice," commented Dr. Schmidt.
"No standard nitinol stent provides the same level of flexibility and radial
strength, and both characteristics are necessary to conform to and support
the SFA and popliteal anatomy."
"SUPERA is a different class of stent, and is exhibiting remarkable
long-term durability in extremely diseased patients," commented Richard C.
Kovach, M.D. and Chair, Department of Endovascular Medicine and Director,
Cardiac Catheterization Laboratory at Deborah Heart and Lung Center in Browns
Mills, New Jersey. "There were several presentations and live cases
throughout LINC highlighting how SUPERA is uniquely suited to the
femoropopliteal anatomy, indicating it may indeed be a market-changing
D. Christopher Metzger, M.D. is the Director of Cardiac and Peripheral
Labs and Medical Director of Clinical Research at Wellmont CVA Heart
Institute. He is an investigator in the SUPERB trial, and also on faculty at
LINC. He remarked, "This data correlates well with our own experience with
the SUPERA stent. I believe we can now confidently stent, knowing that SUPERA
will remain physiologically conformable, will not fracture, and will have
excellent long-term patency. In my opinion, future trials will confirm that
the SUPERA stent will be an excellent front-line therapy for a majority of
infra-inguinal endovascular interventions, especially in areas that have
typically been a 'no-stent' zone."
Independent mechanical testing reported zero stent fractures for any
SUPERA stent assessed after 10 million cycles of 120 degrees flexion and
extension and 20 million cycles of torsion. In comparison, all standard
nitinol stents tested fractured before 100,000 cycles in the flexion and
extension testing and before 1 million cycles in compression load testing.
The SUPERA stent was demonstrated to have a minimum of four times the radial
strength and 360 percent stronger crush resistance than standard nitinol
stents, and completely resisted fracturing, kinking, crushing, and crimping.
"The data from the Leipzig popliteal registry is very promising,"
observed Christopher Owens, President and CEO of IDEV. "We are very excited
about the feedback we are receiving from physicians who have direct
experience with the SUPERA stent. The fact that no other stent has been
evaluated in the popliteal artery, let alone shown this level of patency,
gives us confidence that it's truly a unique device in a growing market."
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 in Europe
for the treatment of biliary strictures produced by malignant neoplasms and
for peripheral vascular use following failed percutaneous transluminal
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 +1-281-525-2000
Donna Lucchesi, Vice President Global Marketing of IDEV Technologies, Incorporated, +1-281-525-2000
Tags: February 8, Germany, Idev Technologies Incorporated, Leipzig