New clinical study shows excellent patency consistent with previous
study results of self-expanding stent-graft in long, complex SFA lesions
FLAGSTAFF, Ariz. & LAS VEGAS--(BUSINESS WIRE)--W.
L. Gore & Associates, Inc. (Gore) today announced positive
results from a prospective, multicenter Investigational Device Exemption
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(IDE) Clinical Study of the GORE® VIABAHN® Endoprosthesis with Heparin
Bioactive Surface* in Japan. The device demonstrated excellent outcomes
in treating long, complex lesions in the superficial femoral artery
(SFA), achieving 88 percent primary patency at 12 months. The findings
were presented during a Gore MEDICAL MASTERY Series event hosted in
conjunction with the Vascular
Interventional Advances 2016 (VIVA) Conference in Las Vegas. (See
detailed information on the study here.)
The prospective single-arm study enrolled 103 patients for analysis
across 15 trial sites. The trial enrolled a challenging patient
population with greater than 10cm long lesions, including 84.5 percent
TASC II C/D lesions, and 65.7 percent of lesions having chronic total
occlusions (CTO). The GORE VIABAHN Endoprosthesis showed favorable
outcomes consistent with previous clinical studies. Primary patency at
12 months in all lesions (average of 21.8 cm) was 88 percent, while
lesions less than or equal to 20 cm recorded 93 percent primary patency.
The study also demonstrated 100 percent limb salvage with zero cases of
acute limb ischemia (ALI), bypass or amputation.
“Eighty-eight percent is an extremely high primary patency for these
long complex lesions with an average length of 22 cm, especially given
the scrutiny of the study design: a prospective, multicenter IDE
clinical study that was core lab adjudicated and reviewed by the
Japanese regulatory authority. The GORE VIABAHN Endoprosthesis, for the
first time in endovascular history, may replace bypass surgery for
femoro-popliteal disease,” said Takao Ohki, MD, Principal Investigator
of the Gore Japan IDE Clinical Study.
The GORE VIABAHN Endoprosthesis is backed by a growing body of clinical
data proving its safety and efficacy in challenging, real-world SFA
lesions. The Gore Japan IDE Clinical Study is now the fourth
prospective, multicenter trial to study performance of the GORE VIABAHN
Endoprosthesis with Heparin Bioactive Surface in complex de novo and
restenotic SFA disease. When all figures and data from the research are
combined, the 359 limbs studied in these four trials have an average
lesion length of 21 cm with 71 percent CTO. The combined 12-month
primary patency seen in the Gore VIPER Clinical Study, VIASTAR Trial,
the GORE VIABAHN Device 25 cm Trial, and the Gore Japan IDE Clinical
Study is 78 percent.
“The GORE VIABAHN Endoprosthesis has an extremely strong, growing body
of clinical data in this category of complex SFA lesions,” said Ray
Swinney, Business Unit Leader for the Gore Peripheral Interventional
Business Unit. “The Gore Japan IDE Clinical Study has once again proven
that the VIABAHN device effectively covers and seals off diseased
tissue, enabling high patencies regardless of lesion length. This
clinical study demonstrates that endoluminal bypass continues to be an
essential component of a physician’s toolkit for treating complex SFA
disease.”
For more information about the GORE VIABAHN Endoprosthesis and other
highlights from VIVA 2016, visit: https://www.goremedical.com/viabahn-patency.
* Heparin Bioactive Surface is synonymous with the CBAS Heparin Surface.
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®, MEDICAL
MASTERY, 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.
Contacts
Chempetitive Group for W. L. Gore & Associates
Andrea Vuturo,
+1 858-457-2436