Mounted CP Stent™

Mounted CP Stent
The Mounted CP Stent™ consists of a bare CP Stent™ pre-mounted on a BIB Catheter. This system allows the physician the flexibility of using the pre-mounted complete system and will save the time required to mount the stent on the catheter.  The CP Stent™ is composed of 0.013” platinum/iridium wire that is arranged in a “zig” pattern, laser welded at each joint and then over brazed with 24K gold.  It allows expansion from 12.0mm to 24.0mm.  The CP Stent is pre-mounted on a BIB (balloon in balloon) catheter.

The Mounted CP Stent™ is indicated for implantation in the native and/or recurrent coarctation of the aorta on patients with the following clinical conditions:

• Stenosis of the aorta resulting in significant anatomic narrowing as determined by angiography or non-invasive imaging, i.e. echocardiography, magnetic resonance imaging (MRI), CT Scan;
• Stenosis of the aorta resulting in hemodynamic alterations, resulting in systolic pressure gradient, systemic hypertension or altered left ventricular function;
• Stenosis of the aorta where balloon angioplasty is ineffective or contraindicated;
• Stenosis diameter >20% of the adjacent vessel diameter.

Covered Mounted CP Stent
The Covered Mounted CP Stent™ consists of a Covered CP Stent™ pre-mounted on a BIB Catheter.  This system allows the physician the flexibility of using the pre-mounted complete system and will save the time required to mount the stent on the catheter.  This may be critical in some cases of aneurysmal repair or in cases where vascular damage has occurred. The Covered CP Stent™ is comprised of the bare CP Stent™ that is covered with an expandable sleeve of ePTFE. 

The Covered Mounted CP Stent™ is indicated for implantation in the native and/or recurrent coarctation of the aorta on patients with the following clinical conditions:

• Stenosis of the aorta resulting in significant anatomic narrowing as determined by angiography or non-invasive imaging, i.e. echocardiography, magnetic resonance imaging (MRI), CT Scan;
• Stenosis of the aorta resulting in hemodynamic alterations, resulting in systolic pressure gradient, systemic hypertension or altered left ventricular function;
• Stenosis of the aorta where balloon angioplasty is ineffective or contraindicated;
• Stenosis diameter <20% of the adjacent vessel diameter;
• Stenosis that would present increased risk of vascular damage or disruption;
• Aneurysm associated with coarctation of the aorta.

BIB Stent Placement Catheter
The BIB Catheter allows for the controlled expansion of the CP Stent™ by utilizing an incremental expansion of the stent.  The inner balloon of the BIB Catheter is ½ the diameter of the outer balloon and is 1.0cm shorter in length.  When the inner balloon is inflated, the stent expansion begins from the center of the stent.  The stent is firmly gripped on to the balloon to allow for fine positioning before the final expansion by inflating the outer balloon.  All BIB Catheters are 110cm in length and utilize a 0.035” guidewire.

Both products are the same units that have been previously for sale in the EU.  NuMED has received approval to market the system consisting of the stent and delivery catheter.

Mounted CP Stent™ Specifications

Stent Length(CM)	Configu-ration(Number of Zigs)	Platinum Wire(Inches)	Outer Balloon Diameter(MM)	Outer Balloon Length(CM)	Shaft Size (FR)	Usable Length (CM)	Guide Wire (Inches)	Rated Burst (ATM)	Mounted CP Stent Cat. No.	Covered Mounted CP Stent Cat. No.
1.6	8	0.013	12.0	2.5	8	110	0.035	7	MCP001	CMCP001
1.6	8	0.013	14.0	2.5	8	110	0.035	6	MCP002	CMCP002
1.6	8	0.013	16.0	2.5	9	110	0.035	5	MCP003	CMCP003
2.2	8	0.013	12.0	2.5	8	110	0.035	7	MCP004	CMCP004
2.2	8	0.013	14.0	2.5	8	110	0.035	6	MCP005	CMCP005
2.2	8	0.013	16.0	2.5	9	110	0.035	5	MCP006	CMCP006
2.2	8	0.013	18.0	2.5	9	110	0.035	4	MCP007	CMCP007
2.8	8	0.013	14.0	3.0	8	110	0.035	6	MCP008	CMCP008
2.8	8	0.013	16.0	3.0	9	110	0.035	5	MCP009	CMCP009
2.8	8	0.013	18.0	3.0	9	110	0.035	4	MCP010	CMCP010
2.8	8	0.013	20.0	3.0	9	110	0.035	4	MCP011	CMCP011
3.4	8	0.013	14.0	3.5	8	110	0.035	6	MCP012	CMCP012
3.4	8	0.013	16.0	3.5	9	110	0.035	5	MCP013	CMCP013
3.4	8	0.013	18.0	3.5	9	110	0.035	4	MCP014	CMCP014
3.4	8	0.013	20.0	3.5	9	110	0.035	4	MCP015	CMCP015
3.4	8	0.013	22.0	3.5	9	110	0.035	3	MCP016	CMCP016
3.9	8	0.013	14.0	4.0	8	110	0.035	6	MCP017	CMCP017
3.9	8	0.013	16.0	4.0	9	110	0.035	5	MCP018	CMCP018
3.9	8	0.013	18.0	4.0	9	110	0.035	4	MCP019	CMCP019
3.9	8	0.013	20.0	4.0	9	110	0.035	4	MCP020	CMCP020
3.9	8	0.013	22.0	4.0	9	110	0.035	3	MCP021	CMCP021
3.9	8	0.013	24.0	4.0	9	110	0.035	3	MCP022	CMCP022
4.5	8	0.013	14.0	4.5	8	110	0.035	6	MCP023	CMCP023
4.5	8	0.013	16.0	4.5	9	110	0.035	5	MCP024	CMCP024
4.5	8	0.013	18.0	4.5	9	110	0.035	4	MCP025	CMCP025
4.5	8	0.013	20.0	4.5	9	110	0.035	4	MCP026	CMCP026
4.5	8	0.013	22.0	4.5	9	110	0.035	3	MCP027	CMCP027
4.5	8	0.013	24.0	4.5	9	110	0.035	3	MCP028	CMCP028
4.5	8	0.013	14.0	5.0	8	110	0.035	6	MCP029	CMCP029
4.5	8	0.013	16.0	5.0	9	110	0.035	5	MCP030	CMCP030
4.5	8	0.013	18.0	5.0	9	110	0.035	4	MCP031	CMCP031
4.5	8	0.013	20.0	5.0	9	110	0.035	4	MCP032	CMCP032
4.5	8	0.013	22.0	5.0	9	110	0.035	3	MCP033	CMCP033
4.5	8	0.013	24.0	5.0	9	110	0.035	3	MCP034	CMCP034

CP Stent™ Foreshortening Chart

The devices listed have CE mark approval.  Any customer or distributor outside of the EU will be subject to their individual country's regulations in regards to the importation and sale of these products.

This publication could include technical or other inaccuracies or typographical errors. Changes are periodically added to the information herein; these changes will be incorporated in the new editions of the publication. NuMED Incorporated may make improvements and/or changes in the product(s) and/or the program(s) described in this publication at any time.