W. L. Gore & Associates (Gore) has obtained the US Food and Drug Administration (FDA) approval for its GORE VIABAHN endoprosthesis for the treatment of stenosis or thrombotic occlusion at the venous anastomosis of synthetic arteriovenous access (AV access) grafts.

The VIABAHN device group has showed statistical superiority of target lesion primary patency as compared to percutaneous transluminal angioplasty in the REVISE clinical study.

Gore claims that the VIABAHN endoprosthesis with heparin bioactive surface is the only device of its kind approved for both the superficial femoral artery and iliac artery use.

The device is constructed with a biocompatible, expanded polytetrafluoroethylene (ePTFE) liner and attached to an external nitinol stent structure. The ePTFE luminal surface of the device has the CARMEDA bioactive heparin surface (CBAS heparin surface).

End-point covalent bonding keeps heparin anchored to the endoprosthesis surface while the bioactive site remains free to interact with the blood.

GORE VIABAHN endoprosthesis

The flexibility of the device allows it to traverse tortuous areas of the superficial femoral artery and conform closely to the complex anatomy of the artery.

GORE VIABAHN endoprosthesis enables a reduction in delivery profile to 6 Fr for 5mm and 6mm devices and 7 Fr for 7mm and 8mm devices and is delivered over a 0.018" or 0.014" guidewire.

Gore Peripheral Interventional business unit business unit leader Ray Swinney noted the company is pleased to expand the GORE VIABAHN endoprosthesis to hemodialysis access.

"We are committed to exceeding the expectations of vascular surgeons, interventional radiologists and interventional nephrologists who have been seeking a better solution for their dialysis access patients," Swinney added.

The device can be precisely deployed and its flexibility allows placement across the elbow and other challenging venous anastomotic locations.

Image: FDA Approves GORE VIABAHN endoprosthesis for revision of arteriovenous access. Photo: Courtesy of Businesswire/ W. L. Gore & Associates, Inc.