WORLD LEADER IN PEDIATRIC CARDIOLOGY

     

Covered CP Stent

Coarctation of the Aorta

 

Available in 8 zig unmounted or pre-mounted


 


 

 

8 ZIG
12mm to 24mm expansion

 

 

Covered CP StentTM 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

 

Covered CP StentTM Details

  • Covered CP StentTM is composed of 0.013 platinum-iridium wire arranged in an 8 zig pattern that is laser welded at each joint and then over brazed with 24K gold.  The stent is then covered with an expandable sleeve of ePTFE.

  • The 8 zig configuration is expandable from 12mm - 24mm in diameter with lengths ranging from 1.6cm to 4.5cm 

  • The pre-mounted configuration is the Covered CP Stent mounted on a BIB Catheter.  This system will save the physician the time required to mount the stent on the catheter.

 

Stent
Length
(CM)

Configuration
(Number
of Zigs)

Covered
Stent
Catalog No.

1.6

8

CVRDCP8Z16

2.2

8

CVRDCP8Z22

2.8

8

CVRDCP8Z28

3.4

8

CVRDCP8Z34

3.9

8

CVRDCP8Z39

4.5

8

CVRDCP8Z45

 

Number of Zigs on Stent

BIB Delivery Catheter Balloon Diameter

Required Introducer with Covered CP Stent

8

12MM

12F

14MM

12F

15MM

12F

16MM

12F

18MM

14F

20MM

14F

22MM

14F

24MM

14F

 

NuMED recommends using the BIB Stent Placement Catheter

 

All of these stents are mounted by hand at NuMED, Inc.  This may be critical in some cases of aneurysmal repair

 

Covered 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)

Covered Mounted
CP Stent
Catalog Number


Covered CP Stent
mounted on a
BIB Catheter

1.6

8

12.0

2.5

12

7

CMCP001

1.6

8

14.0

2.5

12

6

CMCP002

1.6

8

16.0

2.5

12

5

CMCP003

2.2

8

12.0

2.5

12

7

CMCP004

2.2

8

14.0

2.5

12

6

CMCP005

2.2

8

16.0

2.5

12

5

CMCP006

2.2

8

18.0

2.5

14

4

CMCP007

2.8

8

12.0

3.0

12

7

CMCP038

2.8

8

14.0

3.0

12

6

CMCP008

2.8

8

16.0

3.0

12

5

CMCP009

2.8

8

18.0

3.0

14

4

CMCP010

2.8

8

20.0

3.0

14

4

CMCP011

3.4

8

12.0

3.5

12

7

CMCP035

3.4

8

14.0

3.5

12

6

CMCP012

3.4

8

16.0

3.5

12

5

CMCP013

3.4

8

18.0

3.5

14

4

CMCP014

3.4

8

20.0

3.5

14

4

CMCP015

3.4

8

22.0

3.5

14

3

CMCP016

3.9

8

12.0

4.0

12

7

CMCP036

3.9

8

14.0

4.0

12

6

CMCP017

3.9

8

16.0

4.0

12

5

CMCP018

3.9

8

18.0

4.0

14

4

CMCP019

3.9

8

20.0

4.0

14

4

CMCP020

3.9

8

22.0

4.0

14

3

CMCP021

3.9

8

24.0

4.0

14

3

CMCP022

4.5

8

14.0

4.5

12

6

CMCP023

4.5

8

16.0

4.5

12

5

CMCP024

4.5

8

18.0

4.5

14

4

CMCP025

4.5

8

20.0

4.5

14

4

CMCP026

4.5

8

22.0

4.5

14

3

CMCP027

4.5

8

24.0

4.5

14

3

CMCP028

4.5

8

12.0

5.0

12

7

CMCP037

4.5

8

14.0

5.0

12

6

CMCP029

4.5

8

16.0

5.0

12

5

CMCP030

4.5

8

18.0

5.0

14

4

CMCP031

4.5

8

20.0

5.0

14

4

CMCP032

4.5

8

22.0

5.0

14

3

CMCP033

4.5

8

24.0

5.0

14

3

CMCP034

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.

Covered CP Stents for the Prevention or Treatment of Aortic Wall Injury Associated With Coarctation of the Aorta (COASTII: NCT 01278303)
The Covered CP Stent was tested and found to be safe and effective to repair aortic wall injuries and widen the narrow part of the aorta related to coarctation of the aorta.

CP Stent Indications for Use: 
The Covered 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 of disruption; or aneurysm associated with Coarctation of the aorta.

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