|
CP Stent™
Stent Characteristics
The
CP Stent™
is composed of 0.013" platinum / iridium wire that is arranged in a
“zig” pattern, laser welded at each joint and over brazed with 24K gold.
It allows expansion from 12.0 mm to 24.0 mm. The
Covered CP Stent™
is comprised of the Bare CP Stent that is covered with an expandable
sleeve of ePTFE.
Bare Stent
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 Stent
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.
CP Stent™ Specifications
|
Stent
Length
(CM) |
Configuration
(Number
of Zigs) |
Platinum
Wire
(Inches) |
Bare
Stent
Catalog No. |
Covered
Stent
Catalog No. |
|
1.6 |
8 |
0.013 |
CP8Z16 |
Cvrd. CP8Z16 |
|
2.2 |
8 |
0.013 |
CP8Z22 |
Cvrd. CP8Z22 |
|
2.8 |
8 |
0.013 |
CP8Z28 |
Cvrd. CP8Z28 |
|
3.4 |
8 |
0.013 |
CP8Z34 |
Cvrd. CP8Z34 |
|
3.9 |
8 |
0.013 |
CP8Z39 |
Cvrd. CP8Z39 |
|
4.5 |
8 |
0.013 |
CP8Z45 |
Cvrd. CP8Z45 |
NuMED recommends using the BIB Stent Placement Catheter.
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. |
