MINNEAPOLIS –– Medtronic Inc. today announced the CE (Conformité
Européenne) mark and international launch of the Endurant® II AAA Stent Graft
System, which meaningfully expands the options physicians outside the United
States have to treat patients with abdominal aortic aneurysms through a
minimally invasive technique called endovascular aortic repair (EVAR).
An abdominal aortic aneurysm (AAA) is a weakening or bulge
in the segment of the aorta, the bodys main artery, that crosses through the
abdomen. AAA is often called a “silent killer” because it rarely causes
apparent symptoms until rupturing, which usually results in the patients death.
Developed in collaboration with more than 250 physicians
from around the world, the new system encompasses the proven clinical
performance of the market-leading Endurant stent graft platform, while adding
advanced design features that enhance the devices ease of use.
Now available in most European counties, the Endurant II AAA
Stent Graft System carries forward the proven performance of its predecessor,
while adding three distinct enhancements to enable both the most
straightforward and challenging cases:
- Beginning at the point of access, the new lower-profile
delivery system –– with 35 percent extended hydrophilic coating for enhanced
access to challenging anatomies –– allows the 28mm-diameter bifurcated segment
(the most commonly used size) to fit inside an 18 French OD (outer diameter)
catheter (down from 20 French with the original device). - Second, the addition of two new contralateral limb lengths
(156mm and 199mm) enables more configuration options requiring fewer total
pieces. - Finally, the radiopacity of the distal end of the bifurcated
segments contralateral gate has been improved to enhance visibility and aid
with limb insertion, placement and deployment.
“The Endurant II AAA Stent Graft System will confer
considerable confidence to vascular surgeons who use EVAR to treat even the
most complex AAAs,” said Prof. Hence Verhagen, chief of vascular surgery at the
Erasmus Medical
Center in Rotterdam,
the Netherlands.
“Building on the exceptional clinical outcomes of the original system, which
has significantly increased the applicability of EVAR, Endurant II offers an
even better user experience which will benefit even more patients whose AAAs
are detected before rupturing.”
Prof. Verhagen, who led the European clinical trial of the
original Endurant Stent Graft that contributed to that devices approval, was
the first physician to successfully use the new system since it received the CE
mark.
In countries where the Endurant II Stent Graft is approved
with the CE mark, the device is indicated for the endovascular treatment of
abdominal aortic aneurysms in patients with a proximal neck ? 10 mm in length
with ? 60° infrarenal and ? 45° suprarenal angulation and in patients with a
proximal aortic neck ? 15 mm in length with ? 75° infrarenal and ? 60°
suprarenal angulation.
In the United
States, the Endurant II AAA Stent Graft
System is expected to receive approval from the U.S. Food and Drug
Administration (FDA) during 2012.
The original Endurant AAA Stent Graft System received FDA
approval in December 2010 and quickly became the U.S. market leader.
In collaboration with leading clinicians, researchers and
scientists worldwide, Medtronic offers the broadest range of innovative medical
technology for the interventional and surgical treatment of cardiovascular
disease and cardiac arrhythmias.
ABOUT MEDTRONIC
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the
global leader in medical technology – alleviating pain, restoring health and
extending life for millions of people around the world.
Posted by Sean Fenske, Editor-in-Chief, MDT
