WORLD LEADER IN PEDIATRIC CARDIOLOGY

     

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

INFLATED
BALLOON
DIAMETER

CP8Z16
(LENGTH AFTER EXPANSION)

(%
SHORTENING)

CP8Z22(LENGTH AFTER EXPANSION)(%
SHORTENING)

CP8Z28(LENGTH AFTER EXPANSION)(%
SHORTENING)

CP8Z34(LENGTH AFTER EXPANSION)(%
SHORTENING)

CP8Z39(LENGTH AFTER EXPANSION)(%
SHORTENING)

CP8Z45
(LENGTH AFTER EXPANSION)
(%
SHORTENING)

12mm

1.61cm
(2.8%)

2.18cm
(0.8%)

2.62cm
(4.4%)

3.23cm
(3.1%)

3.72cm
(1.9%)

4.17cm (3.8%)

14mm

1.54cm
(6.5%)

2.08cm
(5.4%)

2.56cm
(6.8%)

3.15cm
(5.4%)

3.66cm
(3.6%)

3.97cm (8.4%)

15mm

1.51cm
(8.5%)

2.02cm
(7.9%)

2.51cm
(8.6%)

3.10cm
(7.0%)

3.54cm
(6.6%)

3.94cm (9.2%)

16mm

1.48cm
(10.6%)

1.98cm
(10.1%)

2.45cm
(10.7%)

3.00cm
(9.8%)

3.48cm
(8.2%)

3.84cm (11.4%)

18mm

1.43cm
(13.7%)

1.89cm
(14.0%)

2.38cm
(13.3%)

2.88cm
(13.5%)

3.20cm
(15.6%)

3.71cm (14.5%)

20mm

1.32cm
(20.0%)

1.80cm
(17.9%)

2.30cm
(16.3%)

2.63cm
(20.9%)

2.96cm
(21.9%)

3.27cm (24.7%)

22mm

1.23cm
(25.4%)

1.67cm
(23.9%)

2.09cm
(24.0%)

2.46cm
(26.0%)

2.85cm
(25.0%)

3.15cm (27.3%)

24mm

1.05cm
(36.4%)

1.46cm
(33.8%)

1.91cm
(30.3%)

2.07cm
(37.9%)

2.27cm
(40.1%)

2.83cm (34.9%)

 

BIB DELIVERY
CATHETER
BALLOON DIAMETER AND
INTRODUCER SIZE

REQUIRED INTRODUCER WITH BARE
CP STENT

REQUIRED INTRODUCER WITH COVERED CP STENT

12MM (8F)

10F

12F

14MM (8F)

10F

12F

15MM (9F)

11F

12F

16MM (9F)

11F

12F

18MM (10F)

11F

14F

20MM (10F)

12F

14F

22MM (11F)

12F

14F

24MM (11F)

12F

14F

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.

 

 

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