Catalogue Numbers for GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis - U.S.
VBX Stent Graft catalogue number | Reduced profile VBX Stent Graft catalogue number | Stent labeled/nominal diameter (mm) | Maximum post-dilated stent diameter (mm)* | Stent length (mm) | Catheter length (cm) | Guidewire diameter (in) | Introducer sheath size (Fr) |
---|---|---|---|---|---|---|---|
BXA051501A | BXB051501A | 5 | 8 | 15 | 80 | .035 | 6 |
BXA051901A | BXB051901A | 5 | 8 | 19 | 80 | .035 | 6 |
BXA052901A | BXB052901A | 5 | 8 | 29 | 80 | .035 | 6 |
BXA053901A | BXB053901A | 5 | 8 | 39 | 80 | .035 | 6 |
BXA055901A | BXB055901A | 5 | 8 | 59 | 80 | .035 | 6 |
BXA057901A | BXB057901A | 5 | 8 | 79 | 80 | .035 | 6 |
BXA061501A | BXB061501A | 6 | 8 | 15 | 80 | .035 | 6 |
BXA061901A | BXB061901A | 6 | 8 | 19 | 80 | .035 | 6 |
BXA062901A | BXB062901A | 6 | 8 | 29 | 80 | .035 | 6 |
BXA063901A | BXB063901A | 6 | 8 | 39 | 80 | .035 | 6 |
BXA065901A | BXB065901A | 6 | 8 | 59 | 80 | .035 | 6 |
BXA067901A | BXB067901A | 6 | 8 | 79 | 80 | .035 | 6 |
BXA071501A | BXB071501A | 7 | 11 | 15 | 80 | .035 | 6 |
BXA071901A | BXB071901A | 7 | 11 | 19 | 80 | .035 | 6 |
BXA072901A | BXB072901A | 7 | 11 | 29 | 80 | .035 | 6 |
BXA073901A | BXB073901A | 7 | 11 | 39 | 80 | .035 | 6 |
BXA075901A | BXB075901A | 7 | 11 | 59 | 80 | .035 | 6 |
BXA077901A | BXB077901A | 7 | 11 | 79 | 80 | .035 | 6 |
BXA082901A | BXB082901A | 8 | 11 | 29 | 80 | .035 | 7 |
BXA083901A | BXB083901A | 8 | 11 | 39 | 80 | .035 | 7 |
BXA085901A | BXB085901A | 8 | 11 | 59 | 80 | .035 | 7 |
BXA087901A | BXB087901A | 8 | 11 | 79 | 80 | .035 | 7 |
BXA092901A | BXB092901A | 9 | 13 | 29 | 80 | .035 | 7 |
BXA093901A | BXB093901A | 9 | 13 | 39 | 80 | .035 | 7 |
BXA095901A | BXB095901A | 9 | 13 | 59 | 80 | .035 | 7 |
BXA097901A | BXB097901A | 9 | 13 | 79 | 80 | .035 | 7 |
BXA102901A | Unchanged | 10 | 13 | 29 | 80 | .035 | 8 |
BXA103901A | Unchanged | 10 | 13 | 39 | 80 | .035 | 8 |
BXA105901A | Unchanged | 10 | 13 | 59 | 80 | .035 | 8 |
BXA107901A | Unchanged | 10 | 13 | 79 | 80 | .035 | 8 |
BXA112901A | Unchanged | 11 | 16† | 29 | 80 | .035 | 8 |
BXA113901A | Unchanged | 11 | 16† | 39 | 80 | .035 | 8 |
BXA115901A | Unchanged | 11 | 16† | 59 | 80 | .035 | 8 |
BXA117901A | Unchanged | 11 | 16† | 79 | 80 | .035 | 8 |
BXAL082901A | BXBL082901A | 8 | 16† | 29 | 80 | .035 | 7 |
BXAL083901A | BXBL083901A | 8 | 16† | 39 | 80 | .035 | 7 |
BXAL085901A | BXBL085901A | 8 | 16† | 59 | 80 | .035 | 8 |
BXAL087901A | BXBL087901A | 8 | 16† | 79 | 80 | .035 | 8 |
BXA051502A | BXB051502A | 5 | 8 | 15 | 135 | .035 | 6 |
BXA051902A | BXB051902A | 5 | 8 | 19 | 135 | .035 | 6 |
BXA052902A | BXB052902A | 5 | 8 | 29 | 135 | .035 | 6 |
BXA053902A | BXB053902A | 5 | 8 | 39 | 135 | .035 | 6 |
BXA055902A | BXB055902A | 5 | 8 | 59 | 135 | .035 | 6 |
BXA057902A | BXB057902A | 5 | 8 | 79 | 135 | .035 | 6 |
BXA061502A | BXB061502A | 6 | 8 | 15 | 135 | .035 | 6 |
BXA061902A | BXB061902A | 6 | 8 | 19 | 135 | .035 | 6 |
BXA062902A | BXB062902A | 6 | 8 | 29 | 135 | .035 | 6 |
BXA063902A | BXB063902A | 6 | 8 | 39 | 135 | .035 | 6 |
BXA065902A | BXB065902A | 6 | 8 | 59 | 135 | .035 | 6 |
BXA067902A | BXB067902A | 6 | 8 | 79 | 135 | .035 | 6 |
BXA071502A | BXB071502A | 7 | 11 | 15 | 135 | .035 | 6 |
BXA071902A | BXB071902A | 7 | 11 | 19 | 135 | .035 | 6 |
BXA072902A | BXB072902A | 7 | 11 | 29 | 135 | .035 | 6 |
BXA073902A | BXB073902A | 7 | 11 | 39 | 135 | .035 | 6 |
BXA075902A | BXB075902A | 7 | 11 | 59 | 135 | .035 | 6 |
BXA077902A | BXB077902A | 7 | 11 | 79 | 135 | .035 | 6 |
BXA082902A | BXB082902A | 8 | 11 | 29 | 135 | .035 | 7 |
BXA083902A | BXB083902A | 8 | 11 | 39 | 135 | .035 | 7 |
BXA085902A | BXB085902A | 8 | 11 | 59 | 135 | .035 | 7 |
BXA087902A | BXB087902A | 8 | 11 | 79 | 135 | .035 | 7 |
BXA092902A | BXB092902A | 9 | 13 | 29 | 135 | .035 | 7 |
BXA093902A | BXB093902A | 9 | 13 | 39 | 135 | .035 | 7 |
BXA095902A | BXB095902A | 9 | 13 | 59 | 135 | .035 | 7 |
BXA097902A | BXB097902A | 9 | 13 | 79 | 135 | .035 | 7 |
BXA102902A | Unchanged | 10 | 13 | 29 | 135 | .035 | 8 |
BXA103902A | Unchanged | 10 | 13 | 39 | 135 | .035 | 8 |
BXA105902A | Unchanged | 10 | 13 | 59 | 135 | .035 | 8 |
BXA107902A | Unchanged | 10 | 13 | 79 | 135 | .035 | 8 |
BXA112902A | Unchanged | 11 | 16† | 29 | 135 | .035 | 8 |
BXA113902A | Unchanged | 11 | 16† | 39 | 135 | .035 | 8 |
BXA115902A | Unchanged | 11 | 16† | 59 | 135 | .035 | 8 |
BXA117902A | Unchanged | 11 | 16† | 79 | 135 | .035 | 8 |
BXAL082902A | BXBL082902A | 8 | 16† | 29 | 135 | .035 | 7 |
BXAL083902A | BXBL083902A | 8 | 16† | 39 | 135 | .035 | 7 |
BXAL085902A | BXBL085902A | 8 | 16† | 59 | 135 | .035 | 8 |
BXAL087902A | BXBL087902A | 8 | 16† | 79 | 135 | .035 | 8 |
* Secondary balloon required to post-dilate the stent beyond its nominal deployed diameter (Secondary balloon not included).
† Technical limit of the device as determined by in-vitro testing for the indicated use; device expansion beyond 13 mm was not studied as part of the VBX FLEX Clinical Study and is outside of the approved indication – see Instructions for Use.
INDICATIONS FOR USE IN THE U.S.: The GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis is indicated for the treatment of de novo or restenotic lesions found in iliac arteries with reference vessel diameters ranging from 5 mm–13 mm and lesion lengths up to 110 mm, including lesions at the aortic bifurcation. 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. Refer to Instructions for Use at eifu.goremedical.com for a complete description of all applicable indications, warnings, precautions and contraindications for the markets where this product is available. RXOnly
Products listed may not be available in all markets.
24PL002-EN01