G-Armor Stent® and G-Armor Mounted Stent™
Stents
G-Armor Stent® and G-Armor Mounted Stent™
The G-Armor Stent® was developed in collaboration with Dr. Gareth Morgan, and was first approved for use in coarctation of the aorta in Canada in December 2021. It is composed of platinum/iridium wire that is arranged in a unique ‘zig’ pattern that is laser welded at each joint, and then over brazed with 24K gold. Available in 8 zig and 10 zig configurations for a high expansion range.
NuMED’s Latest Stent Technology
The G-Armor Stent® is manufactured by hand using high-quality materials. The stent is available in both unmounted and pre-mounted (on a BIB® catheter) configurations. The 8 zig G-Armor Stent®. has an expansion range of 12.0 - 24.0 mm. The 10 zig G-Armor Stent™ has an expansion range of 26.0 - 30.0 mm. Thanks to its considerable capacity for expansion, the G-Armor Stent™ can be re-dilated to accommodate a patient’s natural growth, potentially reducing the need for additional stent implantation.
Compared with the CP Stent®, The G-Armor Stent® maintains a longer stent length after expansion. The G-Armor Stent® is compatible with introducers ranging from 13 - 18 F, providing interventionalists with more options than previously available with the CP Stent®. With a lower foreshortening rate, longer stent length, and compatibility with 13 -18 F introducers, the G-Armor Stent® has the capability to treat a broader range of patients.
G-Armor Stent®: Specifications, Instructions for Use, and Forms
Wire: 0.013” Platinum/iridium
Brazing: 24K Gold
Stent Length (cm): 8 Zig: 4.6-6.3 / 10 Zig: 4.6-6.3
Indication: Implantation in native and/or recurrent coarctation of the aorta
All products are subject to individual country regulations in regards to the importation and/or sale of these products. Refer to Instructions for Use for a complete listing of indications, contraindications, warnings, and precautions.
G-Armor Stent® IFUs:
US: IFU-431US-00
CANADA (Sterile IFU): RM0344-78A
Post Market Clinical Follow-up Form
G-Armor Mounted Stent™: Specifications, Instructions for Use, and Forms
Wire: 0.013” Platinum/iridium
Brazing: 24K Gold
Stent Length (cm): 8 Zig: 4.6-6.3 / 10 Zig: 4.6-6.3
Outer Balloon Diameter (mm): 12.0-30.0
Outer Balloon Length (cm): 5.0-6.5
Indication: Implantation in native and/or recurrent coarctation of the aorta
All products are subject to individual country regulations in regards to the importation and/or sale of these products. Refer to Instructions for Use for a complete listing of indications, contraindications, warnings, and precautions.
G-Armor Mounted Stent™ IFUs:
US: IFU-433-US-00
CANADA (Sterile IFU): RM0344-80A
| REF GM™ | Stent Length (cm) | Configuration (# of Zigs) Sort descending | Outer Balloon Diameter (mm) | Outer Balloon Length (cm) | Profile (Fr) | Usable Length (cm) | Guide Wire (inches) | Rated Burst (ATM)* |
|---|---|---|---|---|---|---|---|---|
| GM016 | 5.2 | 8 | 24.0 | 5.5 | 14 | 110 | 0.035 | 3 |
| GM032 | 6.3 | 8 | 24.0 | 6.5 | 14 | 110 | 0.035 | 3 |
| GM033 | 4.6 | 10 | 26.0 | 5.0 | 16 | 110 | 0.035 | 3 |
| GM034 | 4.6 | 10 | 28.0 | 5.0 | 16 | 110 | 0.035 | 2 |
| GM035 | 4.6 | 10 | 30.0 | 5.0 | 16 | 110 | 0.035 | 2 |
| GM036 | 5.2 | 10 | 26.0 | 5.5 | 16 | 110 | 0.035 | 3 |
| GM037 | 5.2 | 10 | 28.0 | 5.5 | 16 | 110 | 0.035 | 2 |
| GM038 | 5.2 | 10 | 30.0 | 5.5 | 16 | 110 | 0.035 | 2 |
| GM039 | 5.7 | 10 | 26.0 | 6.0 | 16 | 110 | 0.035 | 3 |
| GM040 | 5.7 | 10 | 28.0 | 6.0 | 16 | 110 | 0.035 | 2 |
| GM041 | 5.7 | 10 | 30.0 | 6.0 | 16 | 110 | 0.035 | 2 |
| GM042 | 6.3 | 10 | 26.0 | 6.5 | 16 | 110 | 0.035 | 3 |
| GM043 | 6.3 | 10 | 28.0 | 6.5 | 16 | 110 | 0.035 | 2 |
| GM044 | 6.3 | 10 | 30.0 | 6.5 | 16 | 110 | 0.035 | 2 |
| REF G-ARMOR Stent® | Stent Length (cm) | Configuration (Number of Zigs) Sort descending |
|---|---|---|
| G8Z46 | 4.6 | 8 |
| G8Z52 | 5.2 | 8 |
| G8Z57 | 5.7 | 8 |
| G8Z63 | 6.3 | 8 |
| G10Z46 | 4.6 | 10 |
| G10Z52 | 5.2 | 10 |
| G10Z57 | 5.7 | 10 |
| G10Z63 | 6.3 | 10 |
Disclaimer
All products are subject to individual country regulations in regards to the importation and/or sale of these products. Refer to Instructions for Use for a complete listing of indications, contraindications, warnings, and precautions.