Gore designed all-in-one system to preserve iliac artery blood flow
in patients with iliac or aortoiliac aneurysms
FLAGSTAFF, Ariz.--(BUSINESS WIRE)--At the Houston Aortic Symposium today, W.
L. Gore & Associates, Inc. (Gore) announced the Food and Drug
Administration (FDA) approval of the GORE® EXCLUDER® Iliac Branch
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Endoprosthesis (IBE), making it the first off-the-shelf aortic branch
device approved in the United States and the only device indicated for
the endovascular treatment of common iliac artery aneurysms or
aortoiliac aneurysms. The first-of-its-kind device is a complete, fully
engineered system (Gore designed iliac branch and internal iliac
components), which received CE Mark in 2013.
The device is used in conjunction with the GORE® EXCLUDER® AAA
Endoprosthesis to isolate the common iliac artery from systemic blood
flow and preserve blood flow in the external iliac and internal iliac
arteries. The device is built on Gore’s technology platform and designed
using the same durable, expanded polytetrafluoroethylene (ePTFE) graft
and nitinol stent material.
The IBE offers an All-in-One System with improved outcomes for the
treatment of iliac artery aneurysms while preserving flow to the iliac
arteries, which is the recommended treatment by vascular surgery
societies to sustain patient quality of life. Preservation of blood flow
in the internal iliac arteries is found to avoid pelvic flow disruption
and reduce the rate of buttock claudication, sexual dysfunction, and
colonic ischemia.
“Historically, options to preserve flow to the internal iliac arteries
during endovascular aneurysm repair were very limited despite the
involvement of the iliac arteries in about 25 percent of AAA cases,”
said Darren Schneider, MD, Chief of Vascular and Endovascular Surgery
and associate professor of surgery at Weill Cornell Medicine and
Principal Investigator for the national GORE EXCLUDER Iliac Branch
Device Clinical Study.* “However, through our research and the
subsequent FDA approval, physicians now have a new therapeutic option to
preserve pelvic perfusion in order to improve clinical outcomes and
maintain patient quality of life.”
The IBE system provides a treatment range of 6.5-13.5 mm for the
internal iliac arteries, and a treatment range of 6.5-25 mm for the
external iliac arteries. The delivery profile of the loaded catheter
allows the use of a 16 Fr introducer sheath for the iliac branch
component, and a flexible 12 Fr, reinforced introducer sheath for the
internal iliac component.
The GORE EXCLUDER Iliac Branch Device Clinical Study, a prospective,
multicenter, non-randomized, single-arm study designed to assess the
safety and effectiveness of the IBE in treating common iliac artery
aneurysms or aortoiliac aneurysms, completed enrollment in February
2015. A total of 62 patients received the device, which met the FDA
required enrollment of 60 patients. The trial also enrolled an
additional 32 patients through Continued Access (as of February 15,
2016), which expanded treatment options to allow for bilateral placement
of the IBE in addition to unilateral IBE device placement, which was
evaluated in the Primary Enrollment.
“FDA approval of this device is extremely important as it provides an
iliac branch solution for a patient group with a previously unmet
treatment need,” said Ryan Takeuchi, Gore Aortic Business Leader. “The
GORE EXCLUDER Iliac Branch Device has demonstrated high patency,
conformability, and durability and provides physicians with an on-label,
minimally invasive method of preserving flow to the internal and
external iliac arteries. Not only is IBE the first off-the-shelf aortic
branch device approved in the United States, it is a part of a complete
portfolio of aortic branch solutions that are currently in clinical
evaluation.”
The IBE is part of the growing family of GORE EXCLUDER Device products
that share a mission to effectively treat aortic aneurysms through
minimally invasive means, backed by Gore’s highly rated clinical support
team and comprehensive educational offerings.
* Dr. Schneider also serves as a paid consultant to W. L. Gore &
Associates.
ABOUT W. L. GORE & ASSOCIATES
At Gore, we have provided creative therapeutic solutions to complex
medical problems for 40 years. During that time, 40 million innovative
Gore Medical Devices have been implanted, saving and improving the
quality of lives worldwide. Our extensive family of products includes
vascular grafts, endovascular and interventional devices, surgical
meshes for hernia and soft tissue reconstruction, staple line
reinforcement materials, and sutures for use in vascular, cardiac, and
general surgery. We are one of a select few companies to appear on all
of the US “100 Best Companies to Work For” lists since the rankings
debuted in 1984.
ABOUT HOUSTON AORTIC SYMPOSIUM
This two-and-a-half day live educational symposium, which was the ninth
in an annual series, presents and discusses the diagnosis and treatment
paradigms for aortic diseases, including medical, endovascular,
surgical, and hybrid options. A faculty of leading experts from around
the world presents and debates the most important topics in aortic
disease March 3-5, 2016 at the Westin Oaks in Houston, Texas.
In conjunction with and proceeding the symposium, an "Advanced Skills
Workshop for Cardiothoracic Fellows" took place Wednesday, March 2, 2016
at the Methodist Institute for Technology, Innovation, and Education
(MITIE) and the DeBakey Institute for Cardiovascular Education and
Training (DICET), Houston, Texas.
Information on the 2017 “Houston Aortic Symposium” and “Advanced Skills
Workshop,” will be available on www.houstonaorticsymposium.com
in the coming months.
Products listed may not be available in all markets. GORE®,
EXCLUDER®, and designs are trademarks of W. L. Gore & Associates.
AU1160-EN1 FEBRUARY 2016
Contacts
Chempetitive Group for W. L. Gore & Associates
Andrea Vuturo
+1
(312) 997-2436