G-Armor Covered Mounted Stent
Presentational Presentational

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.

  • 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.

    PDFs:

    G-Armor Covered Stent™ Sterile IFUs:

    US: IFU-432US-00

    CANADA (Sterile IFU): RM0344-79A

     

     

    Post Market Clinical Follow-up Form

    Implant Cards

  • 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.

     

    PDFs:

    G-Armor Covered Mounted Stent™ IFUs:

    US: IFU-434US-00

    CANADA (Sterile IFU): RM0344-81A

     

     

    Post Market Clinical Follow-up Form

    Implant Cards

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

* Outer Balloon RBP

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.