TOP OF THE NEWS
called endovascular aortic repair. AAA is a weakening or bulge in
the segment of the aorta, the body’s main artery that crosses through
the abdomen. AAA often is called a“silent killer” because it rarely
causes symptoms until it ruptures, which usually causes death.
Developed in collaboration with more than 250 physicians from
around the world, the new system encompasses the clinical performance of the first-generation Endurant stent graft platform (approved
in the United States in December 2010), while adding design features
that enhance the device’s ease of use, company officials noted.
According to a press release, the Endurant II AAA stent graft
system adds three enhancements to the Endurant line:
• Beginning at the point of access, the new lower-profile deliv-
ery system––with 35 percent extended hydrophilic coating for
enhanced access to challenging anatomies––allows the 28 mm-
diameter bifurcated segment (the most commonly used size) to fit
inside an 18 French outer diameter catheter (down from 20 French
with the original device);
“The Endurant II AAA Stent Graft System will confer consider-
able confidence to vascular surgeons who use EVAR to treat even
the most complex AAAs,”said Hence Verhagen, professor and 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 applica-
bility of EVAR, Endurant II offers an even better user experience,
which will benefit even more patients whose AAAs are detected
Verhagen, who led the European clinical trial of the original
Endurant Stent Graft that contributed to that device’s approval, was
the first physician to successfully use the new system since it received
the CE mark.
In countries where the Endurant II has 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-degree infrarenal and ≤ 45-degree suprarenal angulation and
in patients with a proximal aortic neck ≥ 15 mm in length with ≤ 75-
degree infrarenal and ≤ 60-degree suprarenal angulation.
Officials at Minneapolis, Minn.-based Medtronic expect Endurant
II to receive U.S. premarket approval this year.
Abbott Labs Plans Additional Layoffs
Late last month, Abbott Laboratories unveiled plans to lay off 700
employees as part of its ongoing restructuring efforts.
Most of the layoffs, according to the company, will affect employees who manufacture the company’s heart stents and diagnostic tests. Abbott has seen a decline in stent sales, ahead of the