First-in-Human Experience With the Gore Balloon-Expandable Covered Endoprosthesis in Iliac Artery Occlusive Disease
Holden A, Merrilees S, Buckley B, Connor B, Colgan F, Hill A. First-in-human experience with the Gore Balloon-Expandable Covered Endoprosthesis in iliac artery occlusive disease. Journal of Endovascular Therapy 2017;24(1):11-18.
Abstract
Purpose:
To report the first-in-human iliac artery experience of a new balloon-expandable covered endoprosthesis.
Methods:
A prospective, single-center pilot study recruited 30 symptomatic patients (mean age 64 years; 18 men) to evaluate the safety and early efficacy of the new Gore balloon-expandable covered endoprosthesis for the treatment of de novo or restenotic common and/or external iliac artery lesions. According to protocol, up to 2 discrete lesions could be treated with a maximum total treated length ≤ 110 mm. Follow-up included clinical evaluation with duplex ultrasound at 1, 6, and 12 months. Data are presented through 12-month follow-up. The primary safety endpoint was a composite of device- or procedure-related death, myocardial infarction, or amputation in the treated leg within 30 days of the index procedure. Multiple performance outcomes were also evaluated.
Results:
The primary 30-day safety endpoint was 0%. Per-subject estimates of primary patency, freedom from target lesion revascularization, and freedom from target vessel revascularization were 100% at 1 and 6 months and 96.6% at 12 months. Estimates of assisted primary and secondary patency were both 100% at 12 months. Freedom from major adverse events at 12 months was 100%. Most patients experienced improvements in Rutherford category, ankle-brachial index, and functional status that were sustained to 12 months.
Conclusion:
This positive first-in-human experience with the Gore balloon-expandable covered endoprosthesis suggests this device will have an important role in the management of aortoiliac occlusive disease.
Based on prior clinical data. New evaluation of reduced profile delivery is underway.
Refer to Instructions for Use at eifu.goremedical.com for a complete description of all applicable indications, warnings, precautions and contraindications for the market where this product is available. RXOnly
INDICATIONS FOR USE IN EUROPE: The GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis is indicated for the treatment of:
- De novo or restenotic lesions in the iliac arteries, including lesions at the aortic bifurcation;
- De novo or restenotic lesions in the visceral arteries;
- Isolated visceral, iliac, and subclavian artery aneurysms; or
- Traumatic or iatrogenic vessel injuries in arteries that are located in the chest cavity, abdominal cavity, or pelvis (except for aorta, coronary, innominate, carotid, vertebral, and pulmonary arteries).
The GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis is indicated for use as a bridging stent in branched and fenestrated endovascular aortic aneurysm repair with the following:
- Approved for use branched aortic endovascular grafts constructed of polyester fabric, stainless steel stents, and polypropylene suture with branch diameters of 6/8 mm and lengths of 18/21 mm.
- Approved for use fenestrated aortic endovascular grafts constructed of polyester fabric, stainless steel stents, and fenestrations with polypropylene suture ranging in diameter from 6–8 mm.
CONTRAINDICATIONS: Do not use the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis in patients with known hypersensitivity to heparin, including those patients who have had a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II.