First Patients Enrolled in the Gore RELINE MAX Clinical Study
108 patient trial to add evidence for treatment of in-stent restenosis using
the GORE® VIABAHN® Endoprosthesis
FLAGSTAFF, Ariz.—December 16, 2015—W. L. Gore & Associates (Gore)
announces that the first patients are now enrolled in the Gore RELINE MAX
Clinical Study, a post-approval study to continue to evaluate the GORE®
VIABAHN® Endoprosthesis with Heparin Bioactive Surface for the
treatment of in-stent restenosis in the superficial femoral artery (SFA).
Results of the original Gore RELINE Clinical Study supported the FDA
approval of the GORE VIABAHN Endoprosthesis for the treatment of instent restenosis in the SFA in 2014.
In-stent restenosis or re-occlusion occurs in a significant number of patients
over the course of one year after bare metal stenting, and these rates are
highly dependent on the severity of disease. Previous treatment options
for in-stent restenosis included angioplasty, repeat stenting with another
bare metal stent (BMS), and surgical bypass. The GORE VIABAHN Device
changes the current treatment paradigm for in-stent restenosis by re-lining
the failed BMS and adjacent diseased vessel, providing a long-term
physical barrier that extends the life of the intervention.
The Gore RELINE MAX Clinical Study will enroll 108 patients, largely in the
US, with up to a 27 cm lesion length in patients who have already failed
stenting, making it potentially one of the most difficult patient populations
studied with lower limb disease. “I am thrilled to be one of the many
peripheral experts who are bringing patients into the Gore RELINE MAX
Clinical Study,” said M. Casey Becker, MD, with the Peripheral Structural
and Coronary Interventional Therapies Division, St. Vincent Heart and
Vascular Institute. “By participating in such prospective, multicenter
studies, clinicians provide further evidence of the safety and efficacy of
the GORE VIABAHN Endoprosthesis in a challenging group of patients with
in-stent restenosis, for whom, until recently, percutaneous treatment
options were very limited.”
The flexibility of the GORE VIABAHN Endoprosthesis enables it to traverse
tortuous areas of the SFA and conform closely to the complex anatomy of
the artery. The GORE VIABAHN Endoprosthesis is the lowest profile, most
flexible, self-expanding stent-graft available. It is the only stent-graft to
receive approval for the SFA (de novo, restenotic, and in-stent restenotic
disease), iliac artery, and arteriovenous access revision. The device is
constructed with a durable, reinforced, biocompatible, expanded ePTFE
liner and attached to an external nitinol stent structure. The ePTFE luminal
surface of the GORE VIABAHN Device features the CBAS® Heparin Surface
intended to provide sustained thromboresistance.
The results of the original Gore RELINE Clinical Study, which supported the
FDA approval of the GORE VIABAHN Device for the treatment of in-stent
restenosis in the SFA, found that:
 Subjects in the GORE VIABAHN Device arm of the Gore RELINE
Clinical Study were approximately three times less likely than those
in the PTA arm to require a target lesion revascularization (TLR) after
one year.
 After 12 months, the GORE VIABAHN Endoprosthesis showed a
primary patency of 74.8 percent, compared to only 28 percent for
PTA (P < 0.001).
 With the longest available 25 cm stent-graft, heparin surface, and
ePTFE liner, the GORE VIABAHN Device is a long-lasting solution for
treatment of failed bare stents.
“Up until now, when stents failed, at-risk patients were left with limited
options. By continuing to study the GORE VIABAHN Endoprosthesis in these
complex cases, we can best address the need for more successful
outcomes in this challenging patient population,” said Ben Beckstead,
Clinical and Technical Peripheral Interventional Business Unit Leader. “The
original Gore RELINE Clinical Study saw great results, and we expect to
confirm the benefits of the device for this indication with the Gore RELINE
MAX Clinical Study.”
For more information on the GORE VIABAHN Endoprosthesis, please visit:
http://www.goremedical.com/Viabahn.
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.
GORE®, VIABAHN®, and designs are trademarks of W. L. Gore &
Associates. CBAS® is a trademark of Carmeda AB, a wholly owned
subsidiary of W. L. Gore & Associates.
Contacts
Chempetitive Group for W. L. Gore & Associates
Andrea Vuturo
GoreMedical@Chempetitive.com
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