Covered CP Stent
Presentational Presentational

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

Implant Cards

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

Post Market Clinical Follow-up Form

Implant Cards

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

* Outer Balloon RBP

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.

 

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