Gore Receives FDA Approval for Larger Diameter, Small Profile AAA Endoprosthesis

* Reuters is not responsible for the content in this press release.

Tue Mar 24, 2009 8:04am EDT

Unique Device Design Allows Physicians to Deliver Safe, Effective and Proven
Treatment to Broader Patient Population
FLAGSTAFF, Ariz.--(Business Wire)--
W. L. Gore & Associates (Gore) today announced that it has received approval
from the US Food and Drug Administration (FDA) to market a 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 (AAA) in patients with aortic inner neck diameters up 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 seven to eight cm to accommodate
larger anatomies. 

More than 84,000 GORE EXCLUDER Devices have been implanted in patients
worldwide, making it a widely accepted, minimally invasive treatment option for
individuals with AAA. The 31 mm device will be available for clinical use in the
US in May 2009. It has been available outside of the US since 2004 and has been
implanted in more than 3,300 patients. 

AAA involves swelling or bulging of the abdominal aorta. When the condition is
not treated it can lead to aortic rupture, which is often fatal. Traditional
surgical treatment requires a large incision to place a synthetic graft to
repair the diseased artery. This method can result in long hospital stays and
painful recoveries. The GORE EXCLUDER AAA Endoprosthesis, in contrast, uses a
minimally invasive procedure, thereby reducing the hospital stay, morbidity and
mortality associated with surgery. 

The Gore device is an endovascular graft and stent combination that seals off
the aneurysm and creates a new path for blood flow. The device is inserted
through a small incision in the patient`s leg using a catheter-based delivery
technique. Once the physician has positioned the graft in the diseased aorta,
the device self-expands using radial force. Metal anchors help secure it to the
walls of the aorta. 

"The GORE EXCLUDER AAA Endoprosthesis is backed by more than 11 years of
commercial data that consistently shows the superior 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 will be available in 13, 15 and 17 cm lengths. A
new 32 mm x 4.5 cm Aortic Extender Component will join the device family as
well. Both the new Trunk-Ipsilateral Leg and Aortic Extender Components are 20
Fr introducer sheath compatible. 

ABOUT W. L. GORE & ASSOCIATES

The Gore Medical Products Division has provided creative therapeutic solutions
to complex medical problems for three decades. During that time, more than 25
million innovative Gore Medical Devices have been implanted, saving and
improving the quality of lives worldwide. The extensive Gore Medical family of
products includes vascular grafts, endovascular and interventional devices,
surgical meshes for hernia repair, soft tissue reconstruction, staple line
reinforcement and sutures for use in vascular, cardiac and general surgery. Gore
was recently named one of the best companies to work for by Fortune magazine for
the 12th consecutive year. For more information, visit
http://www.goremedical.com. 

GORE and EXCLUDER® are trademarks of W. L. Gore & Associates. 





Schwartz Communications, Inc. for Gore
Shannon Murphy or Courtney Smith, 415-512-0770 or 781-684-0770
GoreMedical@schwartz-pr.com

Copyright Business Wire 2009

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