The GRAFTMASTER™ RX Coronary Stent Graft System is indicated for use in the treatment of free perforations, defined as free contrast extravasation into the pericardium, in native coronary vessels or saphenous vein bypass grafts ≥ 2.75 mm in diameter. The effectiveness of this device for this use has not been demonstrated. Long-term outcome for this permanent implant is unknown at present.
The effectiveness of this device for this use has not been demonstrated. IRB approval required for use.
GRAFTMASTER™ Diameter | 2.8 - 4.0 mm | 4.5 - 4.8 mm |
---|---|---|
Stent Material | Stainless Steel 316L | Stainless Steel 316L |
Graft Material | Expandable Polytetrafluoroethylene (ePTFE) sandwiched between two identical stents |
Expandable Polytetrafluoroethylene (ePTFE) sandwiched between two identical stents |
Double Wall Thickness (mm) | 0.52 | 0.52 |
Balloon Type | Semi Compliant | Semi Compliant |
Shaft Size (F) | 2.4 - 2.8 | 2.4 - 2.8 |
Nominal Deployment Pressure (ATM) | 15 | 15 |
Rated Burst Pressure (ATM) | 16 | 16 |
Maximum Guide Wire (in) | 0.014 | 0.014 |
Total Length (cm) | 143 | 143 |
Maximum Stent Graft Expansion (mm)* | 5.5 | 5.5 |
Minimum Guide Catheter (in) / (F) | 0.068 / ≥ 6 | 0.074 / ≥ 7 |
Crimped Stent Profile (in) | 0.064 | 0.068 |
Tip Entry Profile (in) | 0.024 | 0.024 |
Maximum Crossing Profile (in) | 0.064 | 0.068 |
Product specification data on file at Abbott.
*The length of the ePTFE foil is shorter than the reported strut length.
After expansion of the stent, the ePTFE foil may be up to 1.6 mm from each end of the stent graft. The covered length of the stented area may be up to 3.2 mm shorter than the stent length. This information must be considered when choosing an appropriately sized stent graft.
ATM | 2.80 mm | 3.50 mm | 4.00 mm | 4.50 mm | 4.80 mm |
---|---|---|---|---|---|
11 | 1.37 | 1.83 | 2.30 | 2.86 | 2.98 |
12 | 1.67 | 2.34 | 2.74 | 3.20 | 3.57 |
13 | 1.91 | 2.47 | 2.90 | 3.30 | 3.89 |
14 | 2.08 | 2.63 | 3.08 | 3.52 | 3.98 |
15 (NOM) | 2.18 | 2.81 | 3.31 | 3.79 | 4.16 |
16 (RBP) | 2.32 | 3.01 | 3.54 | 3.98 | 4.34 |
17 | 2.47 | 3.19 | 3.72 | 4.15 | 4.52 |
18 | 2.62 | 3.32 | 3.86 | 4.31 | 4.64 |
19 | 2.73 | 3.43 | 3.96 | 4.42 | 4.77 |
ATM | 2.80 mm | 3.50 mm | 4.00 mm | 4.50 mm | 4.80 mm |
---|---|---|---|---|---|
11 | 1.89 | 2.35 | 2.82 | 3.38 | 3.50 |
12 | 2.19 | 2.86 | 3.26 | 3.72 | 4.09 |
13 | 2.43 | 2.99 | 3.42 | 3.82 | 4.41 |
14 | 2.60 | 3.15 | 3.60 | 4.04 | 4.50 |
15 (NOM) | 2.70 | 3.33 | 3.83 | 4.31 | 4.68 |
16 (RBP) | 2.84 | 3.53 | 4.06 | 4.50 | 4.86 |
17 | 2.99 | 3.71 | 4.24 | 4.67 | 5.00 |
18 | 3.14 | 3.84 | 4.38 | 4.83 | 5.16 |
19 | 3.25 | 3.95 | 4.48 | 4.94 | 5.29 |
Balloon pressures should be monitored during inflation. Do not exceed rated burst pressure as indicated on product label. Use of pressures higher than specified on the product label may possibly result in a ruptured balloon and potential intimal damage and dissection.
The effectiveness of this device for this use has not been demonstrated.
IRB approval required for use.
GRAFTMASTER™ RX | ||||||
---|---|---|---|---|---|---|
Stent Graft Diameter (mm) |
Stent Graft Length (mm) | 6F/7F (Guide) |
||||
16 | 19 | 26 | ||||
2.8 | 1012580-16 | 1012580-19 | 1012580-26 | 6 | ||
3.5 | 1012581-16 | 1012581-19 | 1012581-26 | 6 | ||
4.0 | 1012582-16 | 1012582-19 | 1012582-26 | 6 | ||
4.5 | 1012583-16 | 1012583-19 | 1012583-26 | 7 | ||
4.8 | 1012584-16 | 1012584-19 | 1012584-26 | 7 |
MAT-2201048 v1.0
Humanitarian Device. Authorized by Federal Law for the use in the treatment of free perforations, defined as free contrast extravasation into the pericardium, in native coronary vessels or saphenous vein bypass grafts ≥ 2.75 mm in diameter. The effectiveness of this device for this use has not been demonstrated.
The GRAFTMASTER™ RX is indicated for use in the treatment of free perforations, defined as free contrast extravasation into the pericardium, in native coronary vessels or saphenous vein bypass grafts ≥ 2.75 mm in diameter. The effectiveness of this device for this use has not been demonstrated. Long-term outcome for this permanent implant is unknown at present.
GRAFTMASTER™ RX is contraindicated for use in:
(See also Individualization of Treatment in IFU)
Note: If, during withdrawal of the catheter, resistance is encountered, use the following steps to improve balloon rewrap:
Adverse events (in alphabetical order) that may be associated with the use of GRAFTMASTER™ RX Coronary Stent Graft in native coronary arteries may include:
MAT-2104728 v1.0
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