Jan 8 2010
W.
L. Gore & Associates (Gore) announced the first human implants
of the next generation Conformable GORE
TAG® Thoracic Endoprosthesis in the United States
for the treatment of traumatic transection of the thoracic aorta. The
first implants were performed by Dr. Joseph Van Camp at Hennepin County
Medical Center in Minneapolis, Minnesota and Dr. Clifford Buckley
assisted by Dr. Ruth Bush at Scott & White Hospital in Temple, Texas.
Dr. Joseph Van Camp, thoracic surgeon at Hennepin County Medical Center
said, “It is exciting to be part of the traumatic transection trial for
the next generation Conformable GORE TAG Device and to investigate the
potential expansion of TEVAR indications to include traumatic
transections.”
“It is exciting to be part of the traumatic transection trial for
the next generation Conformable GORE TAG Device and to investigate the
potential expansion of TEVAR indications to include traumatic
transections.”
Gore received approval of an investigational device exception (IDE) from
the US Food and Drug Administration (FDA) to investigate the use of the
next generation Conformable GORE TAG Thoracic Endoprosthesis in
traumatic aortic transection patients. Dr. Mark Farber from the
University of North Carolina at Chapel Hill will serve as the national
principle investigator (PI) for the Conformable GORE TAG Device
Traumatic Aortic Transection Trial (Gore TAG 08-02).
The next generation Conformable GORE TAG Device portfolio includes
device diameters ranging from 21 – 45 mm as well as tapered devices, and
the study will investigate the treatment of patients with aortic
diameters of 16 – 42 mm. The smaller devices were designed to treat
trauma patients who tend to be younger than patients with degenerative
thoracic aortic disease.
Traumatic thoracic aortic transection often results in death. Injury to
the thoracic aorta from motor vehicle collisions account for up to 15
percent of all deaths, and patients who survive usually have small tears
or partial-thickness tears of the aortic wall with pseudoaneurysm
formation. The proximal descending aorta is at greatest risk from the
shearing forces of sudden deceleration. Therefore, the aorta is at
greatest risk in frontal or side impacts, and falls from heights. Trauma
patients with thoracic aortic transections often have multiple, complex
injuries that increase the risk of standard surgical repair of the
aorta. “We hope to gain insight and knowledge from this trial that will
not only illustrate the GORE TAG Device’s capabilities, but
will also help show that thoracic endografts can offer patients with
traumatic aortic transection a less invasive alternative,” stated Dr.
Farber, the national PI for the Gore TAG 08-02 Trial.
In addition to traumatic aortic transection, the next generation
Conformable GORE TAG Device has been approved to investigate
endovascular repair of other etiologies including thoracic aortic
aneurysm and aortic dissection.
The commercially available GORE TAG Thoracic Endoprosthesis is a
minimally invasive option for safely and effectively treating patients
with descending thoracic aortic aneurysms. It is comprised of an ePTFE
graft with an outer self-expanding nitinol support structure to combine
both device flexibility and material durability. It received pre-market
approval from the FDA in 2005.
“The clinical community has been looking for a minimally invasive
treatment alternative to help treat traumatic aortic transection of the
descending thoracic aorta,” said David Abeyta, Aortic Business Unit
Leader at Gore. “This clinical trial highlights Gore’s legacy in aortic
clinical research and our ongoing commitment to bring to market
innovative technology that will allow the medical community to more
effectively treat patients.”
Investigational Device – Limited by United States Law to Investigational
Use.
http://www.goremedical.com/