G-Armor Covered Stent™ and G-Armor Covered Mounted Stent™
Stents
G-Armor Covered Stent™ and G-Armor Covered Mounted Stent™
The G-Armor Covered Stent™ was developed in collaboration with Dr. Gareth Morgan, and was first approved for use in coarctation of the aorta and RVOT 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. The G-Armor Covered Stent™ is covered with an expandable sheath of ePTFE. Available in 8 zig and 10 zig configurations for a high expansion range.
NuMED’s Latest Stent Technology
The G-Armor Covered Stent™ is manufactured by hand using high-quality materials. This device has undergone rigorous testing to achieve its dual indication labeling. The stent is available in both unmounted and pre-mounted (on a BIB® catheter) configurations. The 8 zig G-Armor Covered Stent™ has an expansion range of 12.0 - 24.0 mm. The 10 zig G-Armor Covered Stent™ has an expansion range of 26.0 - 30.0 mm. Thanks to its considerable capacity for expansion, the G-Armor Covered 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 Covered 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
Covering: Expandable ePTFE
Indication: Implantation in native and/or recurrent coarctation of the aorta and RVOT
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 Covered Stent™ Sterile IFUs:
US: IFU-432US-00
CANADA (Sterile IFU): RM0344-79A
Post Market Clinical Follow-up Form
G-Armor Covered 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
Covering: Expandable ePTFE
Indication: Implantation in native and/or recurrent coarctation of the aorta and RVOT
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 Covered Mounted Stent™ IFUs:
US: IFU-434US-00
CANADA (Sterile IFU): RM0344-81A
| REF GCM™ | Stent Length (cm) | Configuration (# of Zigs) | Outer Balloon Diameter (mm) | Outer Balloon Length (cm) | Profile (Fr) | Usable Length (cm) | Guide Wire (inches) | Rated Burst (ATM)* |
|---|---|---|---|---|---|---|---|---|
| GCM001 | 4.6 | 8 | 12.0 | 5.0 | 14 | 110 | 0.035 | 7 |
| GCM002 | 4.6 | 8 | 14.0 | 5.0 | 14 | 110 | 0.035 | 6 |
| GCM003 | 4.6 | 8 | 15.0 | 5.0 | 14 | 110 | 0.035 | 5 |
| GCM004 | 4.6 | 8 | 16.0 | 5.0 | 14 | 110 | 0.035 | 5 |
| GCM005 | 4.6 | 8 | 18.0 | 5.0 | 14 | 110 | 0.035 | 4 |
| GCM006 | 4.6 | 8 | 20.0 | 5.0 | 16 | 110 | 0.035 | 4 |
| GCM007 | 4.6 | 8 | 22.0 | 5.0 | 16 | 110 | 0.035 | 3 |
| GCM008 | 4.6 | 8 | 24.0 | 5.0 | 16 | 110 | 0.035 | 3 |
| GCM009 | 5.2 | 8 | 12.0 | 5.5 | 14 | 110 | 0.035 | 7 |
| GCM010 | 5.2 | 8 | 14.0 | 5.5 | 14 | 110 | 0.035 | 6 |
| GCM011 | 5.2 | 8 | 15.0 | 5.5 | 14 | 110 | 0.035 | 5 |
| GCM012 | 5.2 | 8 | 16.0 | 5.5 | 14 | 110 | 0.035 | 5 |
| GCM013 | 5.2 | 8 | 18.0 | 5.5 | 14 | 110 | 0.035 | 4 |
| GCM014 | 5.2 | 8 | 20.0 | 5.5 | 16 | 110 | 0.035 | 4 |
| GCM015 | 5.2 | 8 | 22.0 | 5.5 | 16 | 110 | 0.035 | 3 |
| GCM016 | 5.2 | 8 | 24.0 | 5.5 | 16 | 110 | 0.035 | 3 |
| GCM017 | 5.7 | 8 | 12.0 | 6.0 | 14 | 110 | 0.035 | 7 |
| GCM018 | 5.7 | 8 | 14.0 | 6.0 | 14 | 110 | 0.035 | 6 |
| GCM019 | 5.7 | 8 | 15.0 | 6.0 | 14 | 110 | 0.035 | 5 |
| GCM020 | 5.7 | 8 | 16.0 | 6.0 | 14 | 110 | 0.035 | 5 |
| GCM021 | 5.7 | 8 | 18.0 | 6.0 | 14 | 110 | 0.035 | 4 |
| GCM022 | 5.7 | 8 | 20.0 | 6.0 | 16 | 110 | 0.035 | 4 |
| GCM023 | 5.7 | 8 | 22.0 | 6.0 | 16 | 110 | 0.035 | 3 |
| GCM024 | 5.7 | 8 | 24.0 | 6.0 | 16 | 110 | 0.035 | 3 |
| GCM025 | 6.3 | 8 | 12.0 | 6.5 | 14 | 110 | 0.035 | 7 |
| GCM026 | 6.3 | 8 | 14.0 | 6.5 | 14 | 110 | 0.035 | 6 |
| GCM027 | 6.3 | 8 | 15.0 | 6.5 | 14 | 110 | 0.035 | 5 |
| GCM028 | 6.3 | 8 | 16.0 | 6.5 | 14 | 110 | 0.035 | 5 |
| GCM029 | 6.3 | 8 | 18.0 | 6.5 | 14 | 110 | 0.035 | 4 |
| GCM030 | 6.3 | 8 | 20.0 | 6.5 | 16 | 110 | 0.035 | 4 |
| REF G-ARMOR Covered Stent™ | Stent Length (cm) | Configuration (Number of Zigs) |
|---|---|---|
| GC8Z46 | 4.6 | 8 |
| GC8Z52 | 5.2 | 8 |
| GC8Z57 | 5.7 | 8 |
| GC8Z63 | 6.3 | 8 |
| GC10Z46 | 4.6 | 10 |
| GC10Z52 | 5.2 | 10 |
| GC10Z57 | 5.7 | 10 |
| GC10Z63 | 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.