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 in-stent 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.”
ABOUT W. L. GORE & ASSOCIATES
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.