New data from Gore REVISE Clinical Study published online in Journal
of Vascular Surgery illustrate role device can play in maintaining
and salvaging failing dialysis circuits
FLAGSTAFF, Ariz.--(BUSINESS WIRE)--W.
L. Gore & Associates (Gore) today announced the publication of
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clinical study results from the Gore REVISE Clinical Study* in the Journal
of Vascular Surgery (J Vasc Surg) detailing the success of the GORE®
VIABAHN® Endoprosthesis with Heparin Bioactive Surface** (GORE VIABAHN
Endoprosthesis) in AV access graft outflow interventions. Overall, the
device performed significantly better compared to percutaneous
transluminal angioplasty (PTA) alone for treatment of challenging AV
access cases in a real-world patient population, both in terms of
primary patency and in number of interventions over the study period.
Notably, the Gore REVISE Clinical Study is the first AV access
stent-graft study to include patients with thrombosed grafts and
placement of the device across the elbow joint, further demonstrating
the utility of the GORE VIABAHN Endoprosthesis in this demanding
clinical application.
Key findings from the Gore REVISE Clinical Study:
The device delivered a 47 percent improvement in target lesion primary
patency and a 48 percent improvement in circuit primary patency over
PTA alone at six months.
The device demonstrated a 50 percent increase over PTA in target
lesion primary patency at six months when treating thrombosed AV
access circuits.
When placed across the elbow, the GORE VIABAHN Endoprosthesis
delivered 72 percent target lesion primary patency at six months and
83 percent access secondary patency at 24 months (n=22).
The Gore REVISE Clinical Study also showed median time to target
lesion reintervention or graft abandonment with GORE VIABAHN
Endoprosthesis was approximately twice that achieved with PTA (203
versus 108 days).
Placement of GORE VIABAHN Endoprosthesis led to 27 percent fewer
interventions both at the target lesion and in the dialysis access
circuit over a 24-month period compared to PTA.
According to the United States Renal Data System,*** there are over
700,000 patients with end-stage renal disease (ESRD) and nearly 90
percent of those patients are receiving hemodialysis. Arteriovenous
grafts (AVG) are often used to create dialysis circuits for patients.
Failing dialysis circuits often result in the placement of
infection-prone central venous catheters (CVCs) while a new dialysis
access circuit is surgically created and matured. Balloon angioplasty is
a common fix in the event of a failing circuit, but many patients are
unresponsive to the procedure, which has left a gap in treatment
capabilities for difficult anatomies. The Gore REVISE Clinical Study
demonstrated that placement of a stent-graft leads to better patient
outcomes with reduced interventions, a positive finding for all
stakeholders involved in the patient’s care.
“Patients with failing dialysis circuits that are unresponsive to
balloon angioplasty are a real problem for physicians. Historically,
angioplasty has been a popular treatment option, but our study found its
six-month primary patency rates to be well below the ‘reasonable goal’
of 50 percent stated by the 2006 K/DOQI Guidelines for Vascular Access,”
said Thomas Vesely, MD, an Interventional Radiologist from the Vascular
Access Services in St. Louis, Mo., and the primary author of the JVS
paper. “The data shown in the Gore REVISE Clinical Study manuscript
makes a compelling argument for GORE VIABAHN Endoprosthesis use in those
challenging cases.”
In 2013, the Food and Drug Administration (FDA) granted indication for
the GORE VIABAHN Endoprosthesis to maintain and salvage failing dialysis
access circuits. The Gore device is the lowest profile, most flexible,
self-expanding, small-diameter endoprosthesis available and the only
stent or stent-graft to receive approval for the superficial femoral
artery (SFA), in-stent restenosis of bare-metal stents in the SFA, iliac
artery, and AV access. It is constructed with a durable, reinforced,
biocompatible, expanded polytetrafluorethylene (ePTFE) liner and
attached to an external nitinol stent structure. The GORE VIABAHN
Endoprosthesis also features Gore's CBAS Heparin Surface, the proven,
lasting heparin bonding technology designed to resist thrombus formation.
“The Gore REVISE Clinical Study was the clinical support used to gain
the U.S. on-label indication for GORE VIABAHN Endoprosthesis in AV
access,” said Ray Swinney, Business Unit Leader for the Gore Peripheral
Interventional Business Unit. “By expanding indications to include AV
access, GORE VIABAHN Endoprosthesis continues to show how physicians can
depend on the device for complete coverage in complex cases.”
For more information about the Gore REVISE Clinical Study and the
success of the GORE VIABAHN Endoprosthesis in AV access graft outflow
interventions, the Journal of Vascular Surgery article can be
viewed online at http://www.jvascsurg.org/article/S0741-5214(16)30175-6/fulltext.
* Vesely T, DaVanzo W, Behrend T, Dwyer A, Aruny J. Balloon angioplasty
versus Viabahn stent graft for treatment of failing or thrombosed
prosthetic hemodialysis grafts. Journal of Vascular Surgery. In
press.
** Heparin Bioactive Surface is synonymous with the CBAS Heparin Surface
*** Gilbertson DT, Liu J, Xue JL, Louis TA, Solid CA, Ebben JP, Collins
AJ. Projecting the number of patients with end-stage renal disease in
the United States to the year 2015. Journal of the American Society
of Nephrology 2005;16(12):3736-3741.
Products listed may not be available in all markets. GORE® and
VIABAHN® are trademarks of W. L. Gore & Associates. CBAS is a trademark
of Carmeda AB, a wholly owned subsidiary of W. L. Gore & Associates, Inc.
ABOUT US
At Gore Medical, 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. For more information, visit www.goremedical.com.
Contacts
Chempetitive Group for W. L. Gore & Associates