G-Armor Stent
Presentational Presentational

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

Implant Cards

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

Post Market Clinical Follow-up Form

Implant Cards

REF GM™ 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)*
GM031 6.3 8 22.0 6.5 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

* Outer Balloon RBP

REF G-ARMOR Stent® Stent Length (cm) Configuration (Number of Zigs)
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.

 

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