Gore Receives FDA Approval for New GORE® EXCLUDER® AAA Endoprosthesis Components

  Gore Receives FDA Approval for New GORE® EXCLUDER® AAA Endoprosthesis

    Expanded Treatment Options for Abdominal Aortic Aneurysms Provide More
        Patients with Access to Minimally Invasive Endovascular Repair

Business Wire

FLAGSTAFF, Ariz. -- January 14, 2013

W. L. Gore & Associates, Inc. (Gore) has received FDA approval for the new
large diameter 35 mm trunk-ipsilateral leg and 36 mm aortic extender
components, as well as the lower profile 31 mm diameter trunk-ipsilateral leg
and 32 mm aortic extender components of the GORE® EXCLUDER® AAA
Endoprosthesis. The new components provide physicians with a proven and
durable endovascular option to treat abdominal aortic aneurysms (AAAs).

“The expanded sizing options benefit patients and physicians alike. The low
profile sheath allows physicians to use the GORE® EXCLUDER® Device on aortic
necks measuring up to 32 mm, providing more patients with access to minimally
invasive endovascular treatment options using a superior device,” said Scott
L. Stevens, MD, Professor, Department of Surgery, University of Tennessee
Medical Center.

Compatible with an 18 Fr GORE® DrySeal Sheath, the new 35 mm trunk-ipsilateral
leg and 36 mm aortic extender represent some of the lowest profiles for
treating infrarenal aortic necks measuring up to 32 mm in diameter, expanding
the overall treatment range to 19-32 mm. The lower profile 31 mm diameter
trunk-ipsilateral leg and 32 mm aortic extender components allow the
trunk-ipsilateral leg component to be used with an 18 Fr GORE® DrySeal Sheath
and the 32 mm aortic extender component to be used with a 17 Fr compatible
sheath to treat aortic necks with an inner diameter of 27-29 mm.

No changes have been made to the GORE EXCLUDER Device itself—instead, Gore has
implemented an innovative process using ePTFE materials to constrain the
device onto the catheter. This key enhancement to the simple delivery of the
device reduces the access vessel requirement (6.8 mm) for patients requiring
minimally invasive endovascular AAA repair. As with all of the lower profile
devices, the 35 mm trunk-ipsilateral leg endoprosthesis and the 31 mm
trunk-ipsilateral leg endoprosthesis are only available with the GORE® C3®
Delivery System.

“While endovascular repair of AAAs has proven to be a successful alternative
to open surgical repair, physicians continue to seek improvements to the
procedures,” said Fred Weaver, MD, Professor of Surgery at the Keck School of
Medicine of the University of Southern California. “This new lower profile 31
mm trunk-ipsilateral leg will expand the treatment options for more patients
while continuing to provide flexibility and long-term conformability.”

The GORE EXCLUDER AAA Endoprosthesis is an endovascular stent-graft 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 GORE C3 Delivery System uniquely and intuitively enables repositioning of
the stent-graft. The ability to reposition the device may minimize
complications that could occur if the graft needs to be moved after the
initial deployment.

“Expanding our AAA sizing portfolio means that Gore can now offer physicians a
wider range of components using the preferred infrarenal placement on the
lowest profile sheath available today,” said Ryan Takeuchi, Gore Aortic
Business Leader. “All of our innovative product enhancements, such as the ones
announced today, are driven by Gore’s commitment to help physicians provide
the best possible patient care.”

The GORE EXCLUDER AAA Endoprosthesis is the result of collaboration between
leading endovascular aneurysm repair (EVAR) physicians and Gore engineers.
With more than 159,000 devices distributed worldwide, the GORE EXCLUDER Device
is supported by a highly rated clinical support team, a comprehensive
educational offering, and Gore’s outstanding community awareness programs.


The Gore Medical Products Division has provided creative therapeutic solutions
to complex medical problems for more than 35 years. During that time, more
than 35 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 15th consecutive year. For more information, visit

Products listed may not be available in all markets. GORE^®, C3^®, EXCLUDER^®,
^ and designs are trademarks of W. L. Gore & Associates.


Chempetitive Group for W. L. Gore & Associates
Rachel Lear or Erik Clausen
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