GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Provides
Improved Outcomes in Real-World Peripheral Arterial Disease Cases
FLAGSTAFF, Ariz.--(BUSINESS WIRE)--W.
L. Gore & Associates (Gore) has announced that the GORE®
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VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX Stent Graft) has
received U.S. Food & Drug Administration (FDA) approval for treatment of de
novo or restenotic lesions found in iliac arteries, including
lesions at the aortic bifurcation. This marks the availability of the
only balloon expandable stent graft with an indication for the iliac
artery.
“The VBX Stent Graft demonstrated notable immediate and nine-month
safety and efficacy in treating patients with iliac occlusive disease
which can be attributed to the exceptional device design,” said Jean
Bismuth, MD. Dr. Bismuth continued, “Overall, there were multiple
clinical benefits observed, including no median change in the device
length upon deployment and a 100 percent technical success rate with no
occurrences of stent dislodgement or significant residual stenosis. The
study device performed well in disadvantaged lesions, including
occlusions, which speaks to its trackability, radial strength,
conformability, and stent retention.”
Gore VBX FLEX IDE Clinical Study
Of the patients in the Gore VBX FLEX IDE clinical study (n=134), 32
percent presented with TASC II type C or D lesions, 18 percent required
contralateral access to the lesion, and 42 percent involved kissing
stents at the aortic bifurcation. Clinical data from the Gore VBX FLEX
IDE clinical study conducted for FDA approval reflected that the design
components of the VBX Stent Graft were resilient both during stenting
procedures and over time:
100 percent success rate in device delivery and coverage of target
lesions in all study subjects;
100 percent success rate in reducing the target lesion to less than or
equal to 30 percent of the original stenosis;
Zero change in median length of the device upon deployment; and
96.9 percent primary patency at nine-months, including a 95.3 percent
primary patency rate in those patients with TASC II C or D type
lesions.
Further, there were no reported incidences of device dislodgement,
failures in stent integrity, or device-related serious adverse events
through the primary endpoint follow up, meaning no additional costs
incurred for either endovascular or surgical stent removal. The VBX
Stent Graft does not require pre-dilation, which reduces the number of
balloons required, and the longer lengths available reduce the need to
use multiple stents for extensive lesions, both of which also contribute
to procedural cost savings.
AVAILABILITY
“The VBX Stent Graft combines radial strength with trackability and
implanted conformability that results in successful outcomes for
patients, providers and physicians,” said Ray Swinney, Peripheral
Interventional Business Leader at Gore.
The VBX Stent Graft was developed utilizing the small diameter, ePTFE
stent graft technology from the GORE® VIABAHN® Endoprosthesis. The VBX
Stent Graft is available in a range of diameters from 5 to 11
millimeters and lengths of 15, 19, 29, 39, 59, and 79 millimeters to
cover a wide variety of treatment needs.
Gore provides a portfolio of peripheral vascular solutions that are
designed and tested so physicians can more reliably treat patients with
a wide range of challenging peripheral disease presentations and improve
those patients’ outcomes. Each interventional solution is engineered for
durability, accuracy, thromboresistance and conformability, and is
backed by dedicated service to help improve patient outcomes.
For more information, visit goremedical.com/vbx
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 U.S. “100 Best Companies to Work For” lists since the rankings
debuted in 1984.
Products listed may not be available in all markets. GORE®, VBX, and
VIABAHN® are trademarks of W. L. Gore & Associates.
Contacts
Bliss Integrated Communication for Gore Medical
Victoria Aguiar
212-584-5470
or
Liz
DeForest
212-584-5477