Catalogue numbers for GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis
The GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis is not authorized for use with thoracoabdominal and pararenal branched devices indicated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a branch component in Canada.
Catalogue Numbers for GORE® VIABAHN® VBX Balloon Expandable | |||||||
|---|---|---|---|---|---|---|---|
| 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 | BXB082902A | 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.
Catalogue Numbers for GORE® VIABAHN® VBX Balloon Expandable | |||||||
|---|---|---|---|---|---|---|---|
| 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) |
| BXA051502B | BXB051502B | 5 | 8 | 15 | 135 | .035 | 6 |
| BXA051902B | BXB051902B | 5 | 8 | 19 | 135 | .035 | 6 |
| BXA052902B | BXB052902B | 5 | 8 | 29 | 135 | .035 | 6 |
| BXA053902B | BXB053902B | 5 | 8 | 39 | 135 | .035 | 6 |
| BXA055902B | BXB055902B | 5 | 8 | 59 | 135 | .035 | 6 |
| BXA057902B | BXB057902B | 5 | 8 | 79 | 135 | .035 | 6 |
| BXA061502B | BXB061502B | 6 | 8 | 15 | 135 | .035 | 6 |
| BXA061902B | BXB061902B | 6 | 8 | 19 | 135 | .035 | 6 |
| BXA062902B | BXB062902B | 6 | 8 | 29 | 135 | .035 | 6 |
| BXA063902B | BXB063902B | 6 | 8 | 39 | 135 | .035 | 6 |
| BXA065902B | BXB065902B | 6 | 8 | 59 | 135 | .035 | 6 |
| BXA067902B | BXB067902B | 6 | 8 | 79 | 135 | .035 | 6 |
| BXA071502B | BXB071502B | 7 | 11 | 15 | 135 | .035 | 6 |
| BXA071902B | BXB071902B | 7 | 11 | 19 | 135 | .035 | 6 |
| BXA072902B | BXB072902B | 7 | 11 | 29 | 135 | .035 | 6 |
| BXA073902B | BXB073902B | 7 | 11 | 39 | 135 | .035 | 6 |
| BXA075902B | BXB075902B | 7 | 11 | 59 | 135 | .035 | 6 |
| BXA077902B | BXB077902B | 7 | 11 | 79 | 135 | .035 | 6 |
| BXA082902B | BXB082902B | 8 | 11 | 29 | 135 | .035 | 7 |
| BXA083902B | BXB083902B | 8 | 11 | 39 | 135 | .035 | 7 |
| BXA085902B | BXB085902B | 8 | 11 | 59 | 135 | .035 | 7 |
| BXA087902B | BXB087902B | 8 | 11 | 79 | 135 | .035 | 7 |
| BXA092902B | BXB092902B | 9 | 13 | 29 | 135 | .035 | 7 |
| BXA093902B | BXB093902B | 9 | 13 | 39 | 135 | .035 | 7 |
| BXA095902B | BXB095902B | 9 | 13 | 59 | 135 | .035 | 7 |
| BXA097902B | BXB097902B | 9 | 13 | 79 | 135 | .035 | 7 |
| BXA102902B | Unchanged | 10 | 13 | 29 | 135 | .035 | 8 |
| BXA103902B | Unchanged | 10 | 13 | 39 | 135 | .035 | 8 |
| BXA105902B | Unchanged | 10 | 13 | 59 | 135 | .035 | 8 |
| BXA107902B | Unchanged | 10 | 13 | 79 | 135 | .035 | 8 |
| BXA112902B | Unchanged | 11 | 16 | 29 | 135 | .035 | 8 |
| BXA113902B | Unchanged | 11 | 16 | 39 | 135 | .035 | 8 |
| BXA115902B | Unchanged | 11 | 16 | 59 | 135 | .035 | 8 |
| BXA117902B | Unchanged | 11 | 16 | 79 | 135 | .035 | 8 |
| BXAL082902B | BXBL082902B | 8 | 16 | 29 | 135 | .035 | 7 |
| BXAL083902B | BXBL083902B | 8 | 16 | 39 | 135 | .035 | 7 |
| BXAL085902B | BXBL085902B | 8 | 16 | 59 | 135 | .035 | 8 |
| BXAL087902B | BXBL087902B | 8 | 16 | 79 | 135 | .035 | 8 |
* Secondary balloon required to post-dilate the stent beyond its nominal deployed diameter (Secondary balloon not included).
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
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. The GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis is also indicated for use with thoracoabdominal and pararenal branched devices indicated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a branch component.‡
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.
‡ Not applicable to Reduced Profile GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis. (BXB catalogue numbers).