Gore Receives FDA Approval for Larger Diameter, Small Profile
AAA Endoprosthesis
Unique device design allows physicians to deliver safe, effective and proven
treatment to broader patient population
W. L. Gore & Associates (Gore) announced the availability of the 31 mm diameter
version of the GORE EXCLUDER® AAA Endoprosthesis. The device provides
physicians with a safe and effective endovascular option to treat abdominal
aortic aneurysms (AAAs) in patients with aortic inner neck diameters from 27 to 29 mm.
Other important enhancements include a flat-top design that enables greater
production efficiency, an additional pair of proximal anchors to help ensure
excellent fixation, and a lengthening of the trunk from 7 to 8 cm to accommodate
larger anatomies.
Jon Matsumura, MD, National Principal Investigator, stated, "The availability of the larger aortic diameter GORE EXCLUDER® Devices will certainly broaden the range of American patients that can have their aneurysms treated with endovascular repair. This less invasive option has clear benefits of more rapid recovery and lower postoperative risk of fatal complications compared to open surgical repair."
More than 87,000 GORE EXCLUDER® Devices have been implanted in patients worldwide, making it a widely accepted, minimally invasive
treatment option for individuals with AAA. In March 2009, the US Food and Drug Administration (FDA) approved the 31 mm diameter version. It has
been available outside of the US since 2004 and has been implanted in more than 3,300 patients. The 31 mm device has been available in the US
since May 4, 2009.
"The GORE EXCLUDER® AAA Endoprosthesis is backed by more than 11 years of commercial data that consistently shows the excellent
performance of the device," said David Abeyta, Aortic Business Unit Leader at Gore. "It has become a leading option for physicians in North America
for the treatment of AAA. The unique design of the 31 mm device allows physicians to treat patients with a larger range of anatomies, and the fact
that it can be implanted using a minimally invasive procedure means that most patients recover faster and more comfortably."
The 31 mm GORE EXCLUDER® Device is available in 13, 15 and 17 cm lengths, along with a new 32 mm x 4.5 cm Aortic Extender Component.
Both the new Trunk-Ipsilateral Leg and Aortic Extender Components are 20 Fr introducer sheath compatible.
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