CP Stent® and Mounted CP Stent™
Stents
CP Stent® and Mounted CP Stent™
The CP Stent® was developed in collaboration with Dr. John Cheatham, and was first approved for use in Coarctation of the Aorta in the EU in 2004. The USA approval was obtained in 2016. 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.
16+ Years of Clinical Experience
The CP Stent® is manufactured by hand using high-quality materials. The 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 CP Stent® has an expansion range of 12.0 - 24.0 mm. The 10 zig CP Stent® has an expansion range of 26.0 - 30.0 mm. Thanks to its considerable capacity for expansion, the CP Stent® can be re-dilated to accommodate a patient’s natural growth, potentially reducing the need for additional stent implantation.
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
Indication: Implantation in native and/or recurrent coarctation of the aorta
CP Stent® IFUs:
US: IFU-425US
CANADA: RM0344-59E
INTERNATIONAL: RM0344-21N
Post Market Clinical Follow-up Form
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
Indication: Implantation in native and/or recurrent coarctation of the aorta
Mounted CP Stent™ IFUs:
US: IFU-426US
CANADA: RM0344-60E
INTERNATIONAL: RM0344-41L
| REF MCP™ | 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)* |
|---|---|---|---|---|---|---|---|---|
| MCP001 | 1.6 | 8 | 12 | 2.5 | 10.0 | 110 | 0.035 | 7.00 |
| MCP002 | 1.6 | 8 | 14 | 2.5 | 10.0 | 110 | 0.035 | 6.00 |
| MCP003 | 1.6 | 8 | 16 | 2.5 | 11.0 | 110 | 0.035 | 5.00 |
| MCP004 | 2.2 | 8 | 12 | 2.5 | 10.0 | 110 | 0.035 | 7.00 |
| MCP005 | 2.2 | 8 | 14 | 2.5 | 10.0 | 110 | 0.035 | 6.00 |
| MCP006 | 2.2 | 8 | 16 | 2.5 | 11.0 | 110 | 0.035 | 5.00 |
| MCP007 | 2.2 | 8 | 18 | 2.5 | 11.0 | 110 | 0.035 | 4.00 |
| MCP038 | 2.8 | 8 | 12 | 3.0 | 10.0 | 110 | 0.035 | 7.00 |
| MCP008 | 2.8 | 8 | 14 | 3.0 | 10.0 | 110 | 0.035 | 6.00 |
| MCP009 | 2.8 | 8 | 16 | 3.0 | 11.0 | 110 | 0.035 | 5.00 |
| MCP010 | 2.8 | 8 | 18 | 3.0 | 11.0 | 110 | 0.035 | 4.00 |
| MCP011 | 2.8 | 8 | 20 | 3.0 | 12.0 | 110 | 0.035 | 4.00 |
| MCP035 | 3.4 | 8 | 12 | 3.5 | 10.0 | 110 | 0.035 | 7.00 |
| MCP012 | 3.4 | 8 | 14 | 3.5 | 10.0 | 110 | 0.035 | 6.00 |
| MCP013 | 3.4 | 8 | 16 | 3.5 | 11.0 | 110 | 0.035 | 5.00 |
| MCP014 | 3.4 | 8 | 18 | 3.5 | 11.0 | 110 | 0.035 | 4.00 |
| MCP015 | 3.4 | 8 | 20 | 3.5 | 12.0 | 110 | 0.035 | 4.00 |
| MCP016 | 3.4 | 8 | 22 | 3.5 | 12.0 | 110 | 0.035 | 3.00 |
| MCP036 | 3.9 | 8 | 12 | 4.0 | 10.0 | 110 | 0.035 | 7.00 |
| MCP017 | 3.9 | 8 | 14 | 4.0 | 10.0 | 110 | 0.035 | 6.00 |
| MCP018 | 3.9 | 8 | 16 | 4.0 | 11.0 | 110 | 0.035 | 5.00 |
| MCP019 | 3.9 | 8 | 18 | 4.0 | 11.0 | 110 | 0.035 | 4.00 |
| MCP020 | 3.9 | 8 | 20 | 4.0 | 12.0 | 110 | 0.035 | 4.00 |
| MCP021 | 3.9 | 8 | 22 | 4.0 | 12.0 | 110 | 0.035 | 3.00 |
| MCP022 | 3.9 | 8 | 24 | 4.0 | 12.0 | 110 | 0.035 | 3.00 |
| MCP023 | 4.5 | 8 | 14 | 4.5 | 10.0 | 110 | 0.035 | 6.00 |
| MCP024 | 4.5 | 8 | 16 | 4.5 | 11.0 | 110 | 0.035 | 5.00 |
| MCP025 | 4.5 | 8 | 18 | 4.5 | 11.0 | 110 | 0.035 | 4.00 |
| MCP026 | 4.5 | 8 | 20 | 4.5 | 12.0 | 110 | 0.035 | 4.00 |
| MCP027 | 4.5 | 8 | 22 | 4.5 | 12.0 | 110 | 0.035 | 3.00 |
| MCP028 | 4.5 | 8 | 24 | 4.5 | 12.0 | 110 | 0.035 | 3.00 |
| MCP037 | 4.5 | 8 | 12 | 5.0 | 10.0 | 110 | 0.035 | 7.00 |
| MCP029 | 4.5 | 8 | 14 | 5.0 | 10.0 | 110 | 0.035 | 6.00 |
| MCP030 | 4.5 | 8 | 16 | 5.0 | 11.0 | 110 | 0.035 | 5.00 |
| MCP031 | 4.5 | 8 | 18 | 5.0 | 11.0 | 110 | 0.035 | 4.00 |
| MCP032 | 4.5 | 8 | 20 | 5.0 | 12.0 | 110 | 0.035 | 4.00 |
| MCP033 | 4.5 | 8 | 22 | 5.0 | 12.0 | 110 | 0.035 | 3.00 |
| MCP034 | 4.5 | 8 | 24 | 5.0 | 12.0 | 110 | 0.035 | 3.00 |
| MCP059 | 5.0 | 8 | 12 | 5.5 | 10.0 | 110 | 0.035 | 7.00 |
| MCP060 | 5.0 | 8 | 14 | 5.5 | 10.0 | 110 | 0.035 | 6.00 |
| MCP061 | 5.0 | 8 | 16 | 5.5 | 11.0 | 110 | 0.035 | 5.00 |
| MCP062 | 5.0 | 8 | 18 | 5.5 | 11.0 | 110 | 0.035 | 4.00 |
| MCP063 | 5.0 | 8 | 20 | 5.5 | 12.0 | 110 | 0.035 | 4.00 |
| MCP064 | 5.0 | 8 | 22 | 5.5 | 12.0 | 110 | 0.035 | 3.00 |
| MCP065 | 5.0 | 8 | 24 | 5.5 | 12.0 | 110 | 0.035 | 3.00 |
| MCP066 | 5.5 | 8 | 12 | 6.0 | 10.0 | 110 | 0.035 | 7.00 |
| MCP067 | 5.5 | 8 | 14 | 6.0 | 10.0 | 110 | 0.035 | 6.00 |
| MCP068 | 5.5 | 8 | 16 | 6.0 | 11.0 | 110 | 0.035 | 5.00 |
| MCP069 | 5.5 | 8 | 18 | 6.0 | 11.0 | 110 | 0.035 | 4.00 |
| MCP070 | 5.5 | 8 | 20 | 6.0 | 12.0 | 110 | 0.035 | 4.00 |
| MCP071 | 5.5 | 8 | 22 | 6.0 | 12.0 | 110 | 0.035 | 3.00 |
| MCP072 | 5.5 | 8 | 24 | 6.0 | 12.0 | 110 | 0.035 | 3.00 |
| MCP073 | 6.0 | 8 | 12 | 6.0 | 10.0 | 110 | 0.035 | 7.00 |
| MCP074 | 6.0 | 8 | 14 | 6.0 | 10.0 | 110 | 0.035 | 6.00 |
| MCP075 | 6.0 | 8 | 16 | 6.0 | 11.0 | 110 | 0.035 | 5.00 |
| MCP076 | 6.0 | 8 | 18 | 6.0 | 11.0 | 110 | 0.035 | 4.00 |
| MCP077 | 6.0 | 8 | 20 | 6.0 | 12.0 | 110 | 0.035 | 4.00 |
| MCP078 | 6.0 | 8 | 22 | 6.0 | 12.0 | 110 | 0.035 | 3.00 |
| MCP079 | 6.0 | 8 | 24 | 6.0 | 12.0 | 110 | 0.035 | 3.00 |
| MCP040 | 3.9 | 10 | 26 | 4.0 | 16.0 | 110 | 0.035 | 3.00 |
| MCP041 | 3.9 | 10 | 28 | 4.0 | 16.0 | 110 | 0.035 | 2.00 |
| MCP042 | 3.9 | 10 | 30 | 4.0 | 16.0 | 110 | 0.035 | 2.00 |
| MCP044 | 4.5 | 10 | 26 | 5.0 | 16.0 | 110 | 0.035 | 3.00 |
| MCP045 | 4.5 | 10 | 28 | 5.0 | 16.0 | 110 | 0.035 | 2.00 |
| MCP046 | 4.5 | 10 | 30 | 5.0 | 16.0 | 110 | 0.035 | 2.00 |
| MCP048 | 5.0 | 10 | 26 | 5.5 | 16.0 | 110 | 0.035 | 3.00 |
| MCP049 | 5.0 | 10 | 28 | 5.5 | 16.0 | 110 | 0.035 | 2.00 |
| MCP050 | 5.0 | 10 | 30 | 5.5 | 16.0 | 110 | 0.035 | 2.00 |
| MCP052 | 5.5 | 10 | 26 | 6.0 | 16.0 | 110 | 0.035 | 3.00 |
| MCP053 | 5.5 | 10 | 28 | 6.0 | 16.0 | 110 | 0.035 | 2.00 |
| MCP054 | 5.5 | 10 | 30 | 6.0 | 16.0 | 110 | 0.035 | 2.00 |
| MCP056 | 6.0 | 10 | 26 | 6.0 | 16.0 | 110 | 0.035 | 3.00 |
| MCP057 | 6.0 | 10 | 28 | 6.0 | 16.0 | 110 | 0.035 | 2.00 |
| MCP058 | 6.0 | 10 | 30 | 6.0 | 16.0 | 110 | 0.035 | 2.00 |
| REF CP Stent® | Stent Length (cm) | Configuration (Zigs) |
|---|---|---|
| CP8Z16 | 1.6 | 8 |
| CP8Z22 | 2.2 | 8 |
| CP8Z28 | 2.8 | 8 |
| CP8Z34 | 3.4 | 8 |
| CP8Z39 | 3.9 | 8 |
| CP8Z45 | 4.5 | 8 |
| CP8Z50 | 5.0 | 8 |
| CP8Z55 | 5.5 | 8 |
| CP8Z60 | 6.0 | 8 |
| CP10Z39 | 3.9 | 10 |
| CP10Z45 | 4.5 | 10 |
| CP10Z50 | 5.0 | 10 |
| CP10Z55 | 5.5 | 10 |
| CP10Z60 | 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.