Covered CP Stent™ and Covered Mounted CP Stent™
Stents
Covered CP Stent™ and Covered Mounted CP Stent™
The Covered CP Stent™ was developed in collaboration with Dr. John Cheatham, and was the first stent approved in the USA for Coarctation of the Aorta and RVOT. 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 Covered CP Stent™ is covered with an expandable sheath of ePTFE. Available in 8 zig and 10 zig configurations for a high expansion range.
Only Class III Stent in the EU Approved for CoA and RVOT
The Covered CP Stent™ is manufactured by hand using high-quality materials. This device has undergone rigorous testing to achieve its dual indication labeling. The Covered CP Stent™ has a proven safety record through data recorded from both clinical studies as well as post-market feedback. The stent is available in both unmounted and pre-mounted (on a BIB® catheter) configurations. The 8 zig Covered CP Stent™ has an expansion range of 12.0 - 24.0 mm. The 10 zig Covered CP Stent™ has an expansion range of 26.0 - 30.0 mm. Thanks to its considerable capacity for expansion, the Covered CP Stent™ can be re-dilated to accommodate a patient’s natural growth, potentially reducing the need for additional stent implantation.
Covered CP Stent™: Specifications, Instructions for Use, and Forms
Wire: 0.013” Platinum/iridium
Brazing: 24K Gold
Stent Length (cm): 8 Zig: 1.6-6.0 / 10 Zig: 3.9-6.0
Covering: Expandable ePTFE
Indication: Implantation in native and/or recurrent coarctation of the aorta and RVOT
Covered CP Stent™ IFUs:
US: IFU-427US
CANADA: RM0344-61E
INTERNATIONAL: RM0344-68D
Post Market Clinical Follow-up Form
Covered Mounted CP Stent™: Specifications, Instructions for Use, and Forms
Wire: 0.013” Platinum/iridium
Brazing: 24K Gold
Stent Length (cm): 8 Zig: 1.6-6.0 / 10 Zig: 3.9-6.0
Outer Balloon Diameter (mm): 12.0-30.0
Outer Balloon Length (cm): 2.5-6.0
Covering: Expandable ePTFE
Indication: Implantation in native and/or recurrent coarctation of the aorta and RVOT
Covered Mounted CP Stent™ IFUs:
US: IFU-428US
CANADA: RM0344-62E
INTERNATIONAL: RM0344-69D
| REF CMCP | 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)* |
|---|---|---|---|---|---|---|---|---|
| CMCP001 | 1.6 | 8 | 12 | 2.5 | 12 | 110 | 0.035 | 7.0 |
| CMCP002 | 1.6 | 8 | 14 | 2.5 | 12 | 110 | 0.035 | 6.0 |
| CMCP003 | 1.6 | 8 | 16 | 2.5 | 12 | 110 | 0.035 | 5.0 |
| CMCP004 | 2.2 | 8 | 12 | 2.5 | 12 | 110 | 0.035 | 7.0 |
| CMCP005 | 2.2 | 8 | 14 | 2.5 | 12 | 110 | 0.035 | 6.0 |
| CMCP006 | 2.2 | 8 | 16 | 2.5 | 12 | 110 | 0.035 | 5.0 |
| CMCP007 | 2.2 | 8 | 18 | 2.5 | 14 | 110 | 0.035 | 4.0 |
| CMCP038 | 2.8 | 8 | 12 | 3.0 | 12 | 110 | 0.035 | 7.0 |
| CMCP008 | 2.8 | 8 | 14 | 3.0 | 12 | 110 | 0.035 | 6.0 |
| CMCP009 | 2.8 | 8 | 16 | 3.0 | 12 | 110 | 0.035 | 5.0 |
| CMCP010 | 2.8 | 8 | 18 | 3.0 | 14 | 110 | 0.035 | 4.0 |
| CMCP011 | 2.8 | 8 | 20 | 3.0 | 14 | 110 | 0.035 | 4.0 |
| CMCP035 | 3.4 | 8 | 12 | 3.5 | 12 | 110 | 0.035 | 7.0 |
| CMCP012 | 3.4 | 8 | 14 | 3.5 | 12 | 110 | 0.035 | 6.0 |
| CMCP013 | 3.4 | 8 | 16 | 3.5 | 12 | 110 | 0.035 | 5.0 |
| CMCP014 | 3.4 | 8 | 18 | 3.5 | 14 | 110 | 0.035 | 4.0 |
| CMCP015 | 3.4 | 8 | 20 | 3.5 | 14 | 110 | 0.035 | 4.0 |
| CMCP016 | 3.4 | 8 | 22 | 3.5 | 14 | 110 | 0.035 | 3.0 |
| CMCP036 | 3.9 | 8 | 12 | 4.0 | 12 | 110 | 0.035 | 7.0 |
| CMCP017 | 3.9 | 8 | 14 | 4.0 | 12 | 110 | 0.035 | 6.0 |
| CMCP018 | 3.9 | 8 | 16 | 4.0 | 12 | 110 | 0.035 | 5.0 |
| CMCP019 | 3.9 | 8 | 18 | 4.0 | 14 | 110 | 0.035 | 4.0 |
| CMCP020 | 3.9 | 8 | 20 | 4.0 | 14 | 110 | 0.035 | 4.0 |
| CMCP021 | 3.9 | 8 | 22 | 4.0 | 14 | 110 | 0.035 | 3.0 |
| CMCP022 | 3.9 | 8 | 24 | 4.0 | 14 | 110 | 0.035 | 3.0 |
| CMCP023 | 4.5 | 8 | 14 | 4.5 | 12 | 110 | 0.035 | 6.0 |
| CMCP024 | 4.5 | 8 | 16 | 4.5 | 12 | 110 | 0.035 | 5.0 |
| CMCP025 | 4.5 | 8 | 18 | 4.5 | 14 | 110 | 0.035 | 4.0 |
| CMCP026 | 4.5 | 8 | 20 | 4.5 | 14 | 110 | 0.035 | 4.0 |
| CMCP027 | 4.5 | 8 | 22 | 4.5 | 14 | 110 | 0.035 | 3.0 |
| CMCP028 | 4.5 | 8 | 24 | 4.5 | 14 | 110 | 0.035 | 3.0 |
| CMCP037 | 4.5 | 8 | 12 | 5.0 | 12 | 110 | 0.035 | 7.0 |
| CMCP029 | 4.5 | 8 | 14 | 5.0 | 12 | 110 | 0.035 | 6.0 |
| CMCP030 | 4.5 | 8 | 16 | 5.0 | 12 | 110 | 0.035 | 5.0 |
| CMCP031 | 4.5 | 8 | 18 | 5.0 | 14 | 110 | 0.035 | 4.0 |
| CMCP032 | 4.5 | 8 | 20 | 5.0 | 14 | 110 | 0.035 | 4.0 |
| CMCP033 | 4.5 | 8 | 22 | 5.0 | 14 | 110 | 0.035 | 3.0 |
| CMCP034 | 4.5 | 8 | 24 | 5.0 | 14 | 110 | 0.035 | 3.0 |
| CMCP059 | 5.0 | 8 | 12 | 5.5 | 12 | 110 | 0.035 | 7.0 |
| CMCP060 | 5.0 | 8 | 14 | 5.5 | 12 | 110 | 0.035 | 6.0 |
| CMCP061 | 5.0 | 8 | 16 | 5.5 | 12 | 110 | 0.035 | 5.0 |
| CMCP062 | 5.0 | 8 | 18 | 5.5 | 14 | 110 | 0.035 | 4.0 |
| CMCP063 | 5.0 | 8 | 20 | 5.5 | 14 | 110 | 0.035 | 4.0 |
| CMCP064 | 5.0 | 8 | 22 | 5.5 | 14 | 110 | 0.035 | 3.0 |
| CMCP065 | 5.0 | 8 | 24 | 5.5 | 14 | 110 | 0.035 | 3.0 |
| CMCP066 | 5.5 | 8 | 12 | 6.0 | 12 | 110 | 0.035 | 7.0 |
| CMCP067 | 5.5 | 8 | 14 | 6.0 | 12 | 110 | 0.035 | 6.0 |
| CMCP068 | 5.5 | 8 | 16 | 6.0 | 12 | 110 | 0.035 | 5.0 |
| CMCP069 | 5.5 | 8 | 18 | 6.0 | 14 | 110 | 0.035 | 4.0 |
| CMCP070 | 5.5 | 8 | 20 | 6.0 | 14 | 110 | 0.035 | 4.0 |
| CMCP071 | 5.5 | 8 | 22 | 6.0 | 14 | 110 | 0.035 | 3.0 |
| CMCP072 | 5.5 | 8 | 24 | 6.0 | 14 | 110 | 0.035 | 3.0 |
| CMCP073 | 6.0 | 8 | 12 | 6.0 | 12 | 110 | 0.035 | 7.0 |
| CMCP074 | 6.0 | 8 | 14 | 6.0 | 12 | 110 | 0.035 | 6.0 |
| CMCP075 | 6.0 | 8 | 16 | 6.0 | 12 | 110 | 0.035 | 5.0 |
| CMCP076 | 6.0 | 8 | 18 | 6.0 | 14 | 110 | 0.035 | 4.0 |
| CMCP077 | 6.0 | 8 | 20 | 6.0 | 14 | 110 | 0.035 | 4.0 |
| CMCP078 | 6.0 | 8 | 22 | 6.0 | 14 | 110 | 0.035 | 3.0 |
| CMCP079 | 6.0 | 8 | 24 | 6.0 | 14 | 110 | 0.035 | 3.0 |
| CMCP040 | 3.9 | 10 | 26 | 4.0 | 16 | 110 | 0.035 | 3.0 |
| CMCP041 | 3.9 | 10 | 28 | 4.0 | 18 | 110 | 0.035 | 2.0 |
| CMCP042 | 3.9 | 10 | 30 | 4.0 | 18 | 110 | 0.035 | 2.0 |
| CMCP044 | 4.5 | 10 | 26 | 5.0 | 16 | 110 | 0.035 | 3.0 |
| CMCP045 | 4.5 | 10 | 28 | 5.0 | 18 | 110 | 0.035 | 2.0 |
| CMCP046 | 4.5 | 10 | 30 | 5.0 | 18 | 110 | 0.035 | 2.0 |
| CMCP048 | 5.0 | 10 | 26 | 5.5 | 16 | 110 | 0.035 | 3.0 |
| CMCP049 | 5.0 | 10 | 28 | 5.5 | 18 | 110 | 0.035 | 2.0 |
| CMCP050 | 5.0 | 10 | 30 | 5.5 | 18 | 110 | 0.035 | 2.0 |
| CMCP052 | 5.5 | 10 | 26 | 6.0 | 16 | 110 | 0.035 | 3.0 |
| CMCP053 | 5.5 | 10 | 28 | 6.0 | 18 | 110 | 0.035 | 2.0 |
| CMCP054 | 5.5 | 10 | 30 | 6.0 | 18 | 110 | 0.035 | 2.0 |
| CMCP056 | 6.0 | 10 | 26 | 6.0 | 16 | 110 | 0.035 | 3.0 |
| CMCP057 | 6.0 | 10 | 28 | 6.0 | 18 | 110 | 0.035 | 2.0 |
| CMCP058 | 6.0 | 10 | 30 | 6.0 | 18 | 110 | 0.035 | 2.0 |
| REF Covered CP Stent | Stent Length (cm) | Configuration (Zigs) |
|---|---|---|
| CVRDCP8Z16 | 1.6 | 8 |
| CVRDCP8Z22 | 2.2 | 8 |
| CVRDCP8Z28 | 2.8 | 8 |
| CVRDCP8Z34 | 3.4 | 8 |
| CVRDCP8Z39 | 3.9 | 8 |
| CVRDCP8Z45 | 4.5 | 8 |
| CVRDCP8Z50 | 5.0 | 8 |
| CVRDCP8Z55 | 5.5 | 8 |
| CVRDCP8Z60 | 6.0 | 8 |
| CVRDCP10Z39 | 3.9 | 10 |
| CVRDCP10Z45 | 4.5 | 10 |
| CVRDCP10Z50 | 5.0 | 10 |
| CVRDCP10Z55 | 5.5 | 10 |
| CVRDCP10Z60 | 6.0 | 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.