Catalogue numbers for GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface and GORE® VIABAHN® Endoprosthesis
Catalogue Numbers for GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface* and GORE® VIABAHN® Endoprosthesis
GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface.035" Guidewire | ||||||
|---|---|---|---|---|---|---|
| Catalogue Number | Endoprosthesis Labeled Diameter† (mm) | Endoprosthesis Length† (cm) | Catheter Length‡ (cm) | Recommended Vessel Diameter§ (mm) | Device Profile (Fr) | Recommended Balloon Diameter for Device Touch-upII (mm) |
| PAHR050202E | 5 | 2.5 | 120 | 4.0–4.7 | 7 | 5 |
| PAHR050502E | 5 | 5.0 | 120 | 4.0–4.7 | 7 | 5 |
| PAHR050702E | 5 | 7.5 | 120 | 4.0–4.7 | 7 | 5 |
| PAHR051002E | 5 | 10.0 | 120 | 4.0–4.7 | 7 | 5 |
| PAHR051502E | 5 | 15.0 | 120 | 4.0–4.7 | 7 | 5 |
| PAHR052502E | 5 | 25.0 | 120 | 4.0–4.7 | 7 | 5 |
| PAHR060201E | 6 | 2.5 | 75 | 4.8–5.5 | 7 | 6 |
| PAHR060202E | 6 | 2.5 | 120 | 4.8–5.5 | 7 | 6 |
| PAHR060501E | 6 | 5.0 | 75 | 4.8–5.5 | 7 | 6 |
| PAHR060502E | 6 | 5.0 | 120 | 4.8–5.5 | 7 | 6 |
| PAHR060702E | 6 | 7.5 | 120 | 4.8–5.5 | 7 | 6 |
| PAHR061001E | 6 | 10.0 | 75 | 4.8–5.5 | 7 | 6 |
| PAHR061002E | 6 | 10.0 | 120 | 4.8–5.5 | 7 | 6 |
| PAHR061501E | 6 | 15.0 | 75 | 4.8–5.5 | 7 | 6 |
| PAHR061502E | 6 | 15.0 | 120 | 4.8–5.5 | 7 | 6 |
| PAHR062502E | 6 | 25.0 | 120 | 4.8–5.5 | 7 | 6 |
| PAHR070201E | 7 | 2.5 | 75 | 5.6–6.5 | 8 | 7 |
| PAHR070202E | 7 | 2.5 | 120 | 5.6–6.5 | 8 | 7 |
| PAHR070501E | 7 | 5.0 | 75 | 5.6–6.5 | 8 | 7 |
| PAHR070502E | 7 | 5.0 | 120 | 5.6–6.5 | 8 | 7 |
| PAHR070702E | 7 | 7.5 | 120 | 5.6–6.5 | 8 | 7 |
| PAHR071001E | 7 | 10.0 | 75 | 5.6–6.5 | 8 | 7 |
| PAHR071002E | 7 | 10.0 | 120 | 5.6–6.5 | 8 | 7 |
| PAHR071501E | 7 | 15.0 | 75 | 5.6–6.5 | 8 | 7 |
| PAHR071502E | 7 | 15.0 | 120 | 5.6–6.5 | 8 | 7 |
| PAHR072502E | 7 | 25.0 | 120 | 5.6–6.5 | 8 | 7 |
| PAHR080201E | 8 | 2.5 | 75 | 6.6–7.5 | 8 | 8 |
| PAHR080202E | 8 | 2.5 | 120 | 6.6–7.5 | 8 | 8 |
| PAHR080501E | 8 | 5.0 | 75 | 6.6–7.5 | 8 | 8 |
| PAHR080502E | 8 | 5.0 | 120 | 6.6–7.5 | 8 | 8 |
| PAHR080702E | 8 | 7.5 | 120 | 6.6–7.5 | 8 | 8 |
| PAHR081001E | 8 | 10.0 | 75 | 6.6–7.5 | 8 | 8 |
| PAHR081002E | 8 | 10.0 | 120 | 6.6–7.5 | 8 | 8 |
| PAHR081501E | 8 | 15.0 | 75 | 6.6–7.5 | 8 | 8 |
| PAHR081502E | 8 | 15.0 | 120 | 6.6–7.5 | 8 | 8 |
| PAHR082502E | 8 | 25.0 | 120 | 6.6–7.5 | 8 | 8 |
| PAHR090502E | 9 | 5.0 | 120 | 7.6–8.5 | 8 | 9 |
| PAHR090702E | 9 | 7.5 | 120 | 7.6–8.5 | 8 | 9 |
| PAHR091002E | 9 | 10.0 | 120 | 7.6–8.5 | 8 | 9 |
| PAHR091502E | 9 | 15.0 | 120 | 7.6–8.5 | 8 | 9 |
| PAHR100502E | 10 | 5.0 | 120 | 8.6–9.5 | 8 | 10 |
| PAHR101002E | 10 | 10.0 | 120 | 8.6–9.5 | 8 | 10 |
| PAHR101502E | 10 | 15.0 | 120 | 8.6–9.5 | 8 | 10 |
| PAHR110502E | 11 | 5.0 | 120 | 9.6–10.5 | 10 | 12 |
| PAHR111002E | 11 | 10.0 | 120 | 9.6–10.5 | 10 | 12 |
| PAHR130502E | 13 | 5.0 | 120 | 10.6–12.0 | 10¶ | 14 |
| PAHR131002E | 13 | 10.0 | 120 | 10.6–12.0 | 10¶ | 14 |
GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface.018" Guidewire | ||||||
|---|---|---|---|---|---|---|
| Catalogue Number | Endoprosthesis Labeled Diameter† (mm) | Endoprosthesis Length† (cm) | Catheter Length‡ (cm) | Recommended Vessel Diameter§ (mm) | Device Profile (Fr) | Recommended Balloon Diameter for Device Touch-upII (mm) |
| PAJR050202E | 5 | 2.5 | 120 | 4.0–4.7 | 6 | 5 |
| PAJR050502E | 5 | 5.0 | 120 | 4.0–4.7 | 6 | 5 |
| PAJR050702E | 5 | 7.5 | 120 | 4.0–4.7 | 6 | 5 |
| PAJR051002E | 5 | 10.0 | 120 | 4.0–4.7 | 6 | 5 |
| PAJR051502E | 5 | 15.0 | 120 | 4.0–4.7 | 6 | 5 |
| PAJR052502E | 5 | 25.0 | 120 | 4.0–4.7 | 6 | 5 |
| PAJR060202E | 6 | 2.5 | 120 | 4.8–5.5 | 6 | 6 |
| PAJR060502E | 6 | 5.0 | 120 | 4.8–5.5 | 6 | 6 |
| PAJR060702E | 6 | 7.5 | 120 | 4.8–5.5 | 6 | 6 |
| PAJR061002E | 6 | 10.0 | 120 | 4.8–5.5 | 6 | 6 |
| PAJR061502E | 6 | 15.0 | 120 | 4.8–5.5 | 6 | 6 |
| PAJR062502E | 6 | 25.0 | 120 | 4.8–5.5 | 6 | 6 |
| PAJR070202E | 7 | 2.5 | 120 | 5.6–6.5 | 7 | 6 |
| PAJR070502E | 7 | 5.0 | 120 | 5.6–6.5 | 7 | 6 |
| PAJR070702E | 7 | 7.5 | 120 | 5.6–6.5 | 7 | 6 |
| PAJR071002E | 7 | 10.0 | 120 | 5.6–6.5 | 7 | 6 |
| PAJR071502E | 7 | 15.0 | 120 | 5.6–6.5 | 7 | 7 |
| PAJR072502E | 7 | 25.0 | 120 | 5.6–6.5 | 7 | 7 |
| PAJR080202E | 8 | 2.5 | 120 | 6.6–7.5 | 7 | 7 |
| PAJR080502E | 8 | 5.0 | 120 | 6.6–7.5 | 7 | 7 |
| PAJR080702E | 8 | 7.5 | 120 | 6.6–7.5 | 7 | 7 |
| PAJR081002E | 8 | 10.0 | 120 | 6.6–7.5 | 7 | 7 |
| PAJR081502E | 8 | 15.0 | 120 | 6.6–7.5 | 7 | 7 |
| PAJR082502E | 8 | 25.0¶ | 120 | 6.6–7.5 | 7 | 7 |
R in the catalogue number indicates with radiopaque (RO) markers bonded to the graft at each end of endoprosthesis, E is a distribution code.
* As used by Gore, Propaten Bioactive Surface refers to Gore’s proprietary CBAS® Heparin Surface
† Labeled device diameters and lengths are nominal.
‡ Ensure the guidewire is the appropriate size (see Instructions for Use) and has a length at least twice that of the delivery catheter.
§ Recommended endoprosthesis compression within the vessel is approximately 5 – 20%.
II For the 11 and 13 mm diameter devices, balloon inflation pressure should not exceed 8 atm.
¶ The 13 mm diameter device is not compatible with the 10 Fr COOK® FLEXOR® CHECK-FLO® sheath.
Sizing, availability and pricing varies by country.
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 EUROPE: The GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface is indicated for the treatment of:
- de novo or restenotic lesions in the iliac arteries
- de novo or restenotic lesions in the superficial femoral artery and proximal popliteal artery
- in-stent restenotic lesions in the superficial femoral artery and proximal popliteal artery
- stenosis or thrombotic occlusion at the venous anastomosis of synthetic arteriovenous (AV) access grafts and in the venous outflow of dialysis access circuits, including the central veins
- popliteal artery aneurysms and isolated visceral artery aneurysms
- 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)
CONTRAINDICATIONS:
- Non-compliant lesions where full expansion of an angioplasty balloon catheter was not achieved during pre-dilatation, or where lesions cannot be dilated sufficiently to allow passage of the delivery system.
- Do not use the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface in patients with known hypersensitivity to heparin, including those patients who have had a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II.