WORLD LEADER IN PEDIATRIC CARDIOLOGY

     

Covered CP Stent

Coarctation of the Aorta and RVOT*

 

Available in 8 zig and 10 zig, unmounted or pre-mounted


 


 

 

8 ZIG
12mm to 24mm expansion

 

10 ZIG
26mm to 30mm 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

5.0

5.5

6.0

8 ZIG

12

14

15

16

18

20

22

24

10 ZIG

26

28

30

 

Covered CP StentTM Details

  • Covered CP StentTM is composed of 0.013 platinum-iridium wire arranged in either an 8 zig or 10 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 6.0cm

  • The 10 zig configuration is expandable from 26mm - 30mm in diameter with lengths ranging from 3.9cm to 6.0cm

  • 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

5.0

8

CVRDCP8Z50

5.5

8

CVRDCP8Z55

6.0

8

CVRDCP8Z60

3.9

10

CVRDCP10Z39

4.5

10

CVRDCP10Z45

5.0

10

CVRDCP10Z50

5.5

10

CVRDCP10Z55

6.0

10

CVRDCP10Z60

 

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

10

26MM

16F

28MM

18F

30MM

18F

 

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

10 ZIG
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

5.0

8

12.0

5.5

12

7

CMCP059

5.0

8

14.0

5.5

12

6

CMCP060

5.0

8

16.0

5.5

12

5

CMCP061

5.0

8

18.0

5.5

14

4

CMCP062

5.0

8

20.0

5.5

14

4

CMCP063

5.0

8

22.0

5.5

14

3

CMCP064

5.0

8

24.0

5.5

14

3

CMCP065

5.5

8

12.0

6.0

12

7

CMCP066

5.5

8

14.0

6.0

12

6

CMCP067

5.5

8

16.0

6.0

12

5

CMCP068

5.5

8

18.0

6.0

14

4

CMCP069

5.5

8

20.0

6.0

14

4

CMCP070

5.5

8

22.0

6.0

14

3

CMCP071

5.5

8

24.0

6.0

14

3

CMCP072

6.0

8

12.0

6.0

12

7

CMCP073

6.0

8

14.0

6.0

12

6

CMCP074

6.0

8

16.0

6.0

12

5

CMCP075

6.0

8

18.0

6.0

14

4

CMCP076

6.0

8

20.0

6.0

14

4

CMCP077

6.0

8

22.0

5.0

14

3

CMCP078

6.0

8

24.0

6.0

14

3

CMCP079

3.9

10

26.0

4.0

16

3

CMCP040

3.9

10

28.0

4.0

18

2

CMCP041

3.9

10

30.0

4.0

18

2

CMCP042

4.5

10

26.0

5.0

16

3

CMCP044

4.5

10

28.0

5.0

18

2

CMCP045

4.5

10

30.0

5.0

18

2

CMCP046

5.0

10

26.0

5.5

16

3

CMCP048

5.0

10

28.0

5.5

18

2

CMCP049

5.0

10

30.0

5.5

18

2

CMCP050

5.5

10

26.0

6.0

16

3

CMCP052

5.5

10

28.0

6.0

18

2

CMCP053

5.5

10

30.0

6.0

18

2

CMCP054

6.0

10

26.0

6.0

16

3

CMCP056

6.0

10

28.0

6.0

18

2

CMCP057

6.0

10

30.0

6.0

18

2

CMCP058

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 10 zig Stent Configuration
12mm Diameter 14mm Diameter 15mm Diameter 16mm Diameter 18mm Diameter 20mm Diameter 22mm Diameter 24mm Diameter 26mm Diameter 28mm Diameter 30mm Diameter
1 2.75 3.22 3.49 3.75 3.94 4.02 4.2 4.28 10.25 10.94 11.96
2 2.85 3.32 3.59 3.85 4.36 4.13 4.33 4.5 10.77 11.39 12.42
3 5.85 6.91 6.89 7.79 8.54 9.2 10.16 10.57 11.27 11.87 12.89
4 6.12 7 7.02 7.95 8.71 9.63 10.4 11.08 12.05 12.97 13.81
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 10 zig Stent Configuration
12mm Diameter 14mm Diameter 15mm Diameter 16mm Diameter 18mm Diameter 20mm Diameter 22mm Diameter 24mm Diameter 26mm Diameter 28mm Diameter 30mm Diameter
0.5                   22.85 24.84
1 10.73 13.08 13.45 14.87 16.85 17.91 20.52 22.79 21.62 23.87 25.8
1.5                   24.87 26.81
2 10.86 13.27 14.16 15.1 17.06 18.38 21.46 23.95 23.34 27.44 29.94
3 11.15 13.5 14.55 15.68 17.64 19.42 21.98 24.68 25.44    
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 5 5.5 6
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%) 4.71cm (6.2%) 5.25cm (5.0%) 5.84cm (4.5%)
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%) 4.58cm (8.7%) 5.11cm (7.6%) 5.67cm (7.3%)
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%) 4.50cm (10.3%) 4.98cm (10.0%) 5.55cm (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%) 4.42cm (11.9%) 4.91cm (11.2%) 5.43cm (11.2%)
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%) 4.21cm (16.1%) 4.70cm (15.1%) 5.20cm (14.9%)
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%) 3.96cm (21.0%) 4.43cm (20.00%) 4.92cm (19.5%)
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%) 3.71cm (26.0%) 4.09cm (26.1%) 4.55cm (25.5%)
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%) 3.33cm (33.5%) 3.72cm (32.8%) 4.14cm (32.3%)
10 Zig 26         3.17cm (18.33%) 3.44m (22.09%) 4.10cm (17.34%) 4.24cm (23.32%) 4.85cm (20.20%)
28         2.96cm (23.68%) 3.24cm (26.75%) 3.71cm (25.11%) 4.00cm (27.58%) 4.39cm (27.87%)
30         2.58cm (33.45%) 3.09cm (30.16%) 3.26cm (34.34%) 3.64cm (34.17%) 4.11cm (32.55%)

 

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.

Pulmonary Artery Repair With Covered Stents (PARCS: NCT01824160)
The Covered CP Stent was tested and found to be safe and effective to use as a treatment of right ventricle to pulmonary artery (right ventricular outflow tract) conduit disruptions that are identified during conduit pre-dilatation procedures performed in preparation for transcatheter pulmonary valve replacement (TPVR).

CP Stent Indications for Use: 
The Covered CP Stent is indicated for use in the treatment of native and/or recurrent coarctation of the aorta involving the aortic isthmus or first segment of the descending aorta where there is adequate size and patency of at least one femoral artery associated with one or more of the following: acute or chronic wall injury; nearly atretic descending aorta of 3 mm or less in diameter; a non-compliant stenotic aortic segment found on pre-stent balloon dilation; a genetic or congenital syndrome associated with aortic wall weakening or ascending aortic aneurysm. Covered CP Stent is indicated for use in the treatment of right ventricle to pulmonary artery (right ventricular outflow tract) conduit disruptions that are identified during conduit pre-dilatation procedures performed in preparation for transcatheter pulmonary valve replacement.

BIB Indications for Use:
The BIB Catheter Balloon is indicated for CP Stent/Covered CP Stent placement in vessels over 8mm in diameter.


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

 

 

 


 

 

Available to U.S. Customers through your B. Braun Interventional Systems Sales Representative or 1-877-836-2228.

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