The GORE® VIABAHN® Endoprosthesis is an easy-to-use device which allows clinicians to reline patients' arteries to improve blood flow.
Covered or lined stents originally developed for the treatment of peripheral artery obstructive disease following balloon angioplasty have become a key tool in the clinician’s arsenal for minimally invasive peripheral therapies. Treatments include a wide range of vascular disease and lesions, aneurysms, dissections, failed PTA, stenosis, trauma, occlusions and fistulas.
GORE® VIABAHN® Endoprosthesis, the next generation vascular endoprosthesis, deploys from the tip to the hub. The endoprosthesis is a self-expanding, nitinol stent lined with an ultra-thin ePTFE graft, and can be inserted percutaneously through the groin or upper thigh. This delivery method can reduce a patient's hospital stay to as little as one day.
Positive results from a prospective, multicenter Investigational Device Exemption (IDE) Clinical Study of the GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface* in Japan have been published by the Journal of Vascular Surgery. The study demonstrated1:
- 88% 12-month primary patency in long, complex SFA lesions (n = 103)**
- 21.8 cm average lesion length
- 65.7% chronic total occlusions (CTOs)
- 84.5% TASC II C&D lesions
The Gore Japan IDE Clinical Study has once again proven that the GORE® VIABAHN® Endoprosthesis effectively covers and seals off diseased tissue, enabling high patencies independent 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.
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.
* Heparin Bioactive Surface is synonymous with the CBAS Heparin Surface.
** GORE® VIABAHN® Endoprosthesis Japan IDE Clinical Study demonstrated 12-month primary patency of 92% as defined by evidence of flow with no Target Lesion Revascularization (TLR). The same study demonstrated 88% 12-month primary patency when defined by PSVR of < 2.5 without a TLR.
1. Ohki T, Kichikawa K, Yokoi H, et al. Outcomes of the Japanese multicenter Viabahn trial of endovascular stent grafting for superficial femoral artery lesions. Journal of Vascular Surgery 2017;66(1):130-142.e1