WORLD LEADER IN PEDIATRIC CARDIOLOGY

     

CP Stent®
Coarctation of the Aorta*

 

This stent comes in both unmounted and pre-mounted configurations.


Stent Characteristics

The CP Stent
® is composed of 0.013” platinum/iridium wire that is arranged in a “zig” pattern that is laser welded at each joint and then over brazed with 24K gold. The 8 zig configuration allows expansion from 12 mm to 24 mm.

The pre-mounted configuration is the bare CP Stent
® mounted on a BIB® Catheter. This system will save the physician the time required to mount the stent on the catheter. All of these stents are mounted by hand at NuMED, Inc.

 

NuMED recommends using the BIB Stent Placement Catheter.

 

* Refer to the Instructions for Use for the complete listing of Indication, Contraindications, Warnings, and Precautions.

CP Stent® Size Matrix

Configuration(Number of Zigs)

Diameter(mm)

Stent Length (cm)

1.6

2.2

2.8

3.4

3.9

4.5

8 ZIG

12

14

15

16

18

20

22

24

 

CP Stent® Specifications

Stent Length (CM)

Configuration
(Number of Zigs)

Bare Stent
Catalog No.

1.6

8

CP8Z16

2.2

8

CP8Z22

2.8

8

CP8Z28

3.4

8

CP8Z34

3.9

8

CP8Z39

4.5

8

CP8Z45

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Number of Zigs
on Stent

BIB Delivery Catheter
Balloon Diameter

Required Introducer
with Bare CP Stent

8

12MM

10F

14MM

10F

15MM

11F

16MM

11F

18MM

11F

20MM

12F

22MM

12F

24MM

12F

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Mounted CP Stent System Specifications

Stent
Length
(cm)

Stent Configuration(Number of Zigs)

Outer Balloon Diameter(mm)

Outer Balloon Length (cm)

Profile
(Fr)

Rated Burst (atm)

Mounted CP Stent Catalog Number

1.6

8

12.0

2.5

10

7

MCP001

1.6

8

14.0

2.5

10

6

MCP002

1.6

8

16.0

2.5

11

5

MCP003

2.2

8

12.0

2.5

10

7

MCP004

2.2

8

14.0

2.5

10

6

MCP005

2.2

8

16.0

2.5

11

5

MCP006

2.2

8

18.0

2.5

11

4

MCP007

2.8

8

12.0

3.0

10

7

MCP038

2.8

8

14.0

3.0

10

6

MCP008

2.8

8

16.0

3.0

11

5

MCP009

2.8

8

18.0

3.0

11

4

MCP010

2.8

8

20.0

3.0

12

4

MCP011

3.4

8

12.0

3.5

10

7

MCP035

3.4

8

14.0

3.5

10

6

MCP012

3.4

8

16.0

3.5

11

5

MCP013

3.4

8

18.0

3.5

11

4

MCP014

3.4

8

20.0

3.5

12

4

MCP015

3.4

8

22.0

3.5

12

3

MCP016

3.9

8

12.0

4.0

10

7

MCP036

3.9

8

14.0

4.0

10

6

MCP017

3.9

8

16.0

4.0

11

5

MCP018

3.9

8

18.0

4.0

11

4

MCP019

3.9

8

20.0

4.0

12

4

MCP020

3.9

8

22.0

4.0

12

3

MCP021

3.9

8

24.0

4.0

12

3

MCP022

4.5

8

14.0

4.5

10

6

MCP023

4.5

8

16.0

4.5

11

5

MCP024

4.5

8

18.0

4.5

11

4

MCP025

4.5

8

20.0

4.5

12

4

MCP026

4.5

8

22.0

4.5

12

3

MCP027

4.5

8

24.0

4.5

12

3

MCP028

4.5

8

12.0

5.0

10

7

MCP037

4.5

8

14.0

5.0

10

6

MCP029

4.5

8

16.0

5.0

11

5

MCP030

4.5

8

18.0

5.0

11

4

MCP031

4.5

8

20.0

5.0

12

4

MCP032

4.5

8

22.0

5.0

12

3

MCP033

4.5

8

24.0

5.0

12

3

MCP034

All catheters have a usable length of 110cm and use a 0.035” Guidewire

* Refer to the Instructions for Use for the complete listing of Indication, Contraindications, Warnings, and Precautions.

CP Stent® Balloon Sizing Chart

INNER BALLOON Balloon Pressure (atm) 8 zig Stent Configuration
12mm Diameter 14mm Diameter 15mm Diameter 16mm Diameter 18mm Diameter 20mm Diameter 22mm Diameter 24mm Diameter
1 2.75 3.22 3.49 3.75 3.94 4.02 4.2 4.28
2 2.85 3.32 3.59 3.85 4.36 4.13 4.33 4.5
3 5.85 6.91 6.89 7.79 8.54 9.2 10.16 10.57
4 6.12 7 7.02 7.95 8.71 9.63 10.4 11.08
4.5             10.84 11.94
5 6.2 7.08 7.1 8.04 8.91 10    

 

OUTER BALLOON Balloon Pressure (atm) 8 zig Stent Configuration
12mm Diameter 14mm Diameter 15mm Diameter 16mm Diameter 18mm Diameter 20mm Diameter 22mm Diameter 24mm Diameter
0.5                
1 10.73 13.08 13.45 14.87 16.85 17.91 20.52 22.79
1.5                
2 10.86 13.27 14.16 15.1 17.06 18.38 21.46 23.95
3 11.15 13.5 14.55 15.68 17.64 19.42 21.98 24.68
4 11.33 13.68 14.88 15.93 18.06 20.07    
5 11.62 13.87 15.06 16.19        
6 11.8 13.98            
7 12.04              

CP Stent® Foreshortening Chart

Stent Configuration (Number of Zigs) Inflated Balloon Diamter (mm) Stent Length (cm)
1.6 2.2 2.8 3.4 3.9 4.5
Stent Length After Expansion
(PERCENTAGE SHORTENING)
8 ZIG 12 1.61cm (2.8%) 2.18cm (0.8%) 2.62cm (4.4%) 3.23cm (3.1%) 3.72cm (1.9%) 4.17cm (3.8%)
14 1.54cm (6.5%) 2.08cm (5.4%) 2.56cm (6.8%) 3.15cm (5.4%) 3.66cm (3.6%) 3.97cm (8.4%)
15 1.51cm (8.5%) 2.02cm (7.9%) 2.51cm (8.6%) 3.10cm (7.0%) 3.54cm (6.6%) 3.94cm (9.2%)
16 1.48cm (10.6%) 1.98cm (10.1%) 2.45cm (10.7%) 3.00cm (9.8%) 3.48cm (8.2%) 3.84cm (11.4%)
18 1.43cm (13.7%) 1.89cm (14.0%) 2.38cm (13.3%) 2.88cm (13.5%) 3.20cm (15.6%) 3.71cm (14.5%)
20 1.32cm (20.0%) 1.80cm (17.9%) 2.30cm (16.3%) 2.63cm (20.9%) 2.96cm (21.9%) 3.27cm (24.7%)
22 1.23cm (25.4%) 1.67cm (23.9%) 2.09cm (24.0%) 2.46cm (26.0%) 2.85cm (25.0%) 3.15cm (27.3%)
24 1.05cm (36.4%) 1.46cm (33.8%) 1.91cm (30.3%) 2.07cm (37.9%) 2.27cm (40.1%) 2.83cm (34.9%)


 

SAFETY AND EFFECTIVENESS CLINICAL DATA:
Coarctation Of the Aorta Stent Trial (COAST: NCT00552812) The CP Stent® was tested and found to be safe and effective to widen the narrow part of the aorta related to coarctation of the aorta.

CP Stent® Indications for Use:
The 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.

BIB® Indications for Use:
The BIB® Catheter Balloon is indicated for stent placement in vessels over 8mm in diameter.


Reference the IFU for a complete listing of indications, contraindications, warnings and precautions.

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.

 

 

  ©2018 NuMED, Inc., All Rights Reserved. Rev. 2018-08-20