NuMED CP STENT Mode D'emploi page 4

Stent Deployment
1. Use of the tools supplied with the stent is necessary to defeat the hemostasis valve without
damaging the stent. Refer to insert IFU-CPCE. Once the stent is past the hemostasis valve, the tool
must be pulled out of the valve.
2. The assembly is advanced through the long delivery sheath and over the stiff guidewire into the desired
location for implant.
3. After correct positioning of the stent, pull back on the sheath to expose the stent. Confirm proper stent
position by a small injection of contrast through the sidearm of sheath or through a second catheter. Expand
the stent by inflating the balloon catheter to the recommended inflation pressure. Do not exceed the balloon
manufacturer's rated burst pressure.
Delivery System Withdrawal
1. Once the stent is expanded, deflate the balloon and rotate to ensure the stent is free and properly deployed.
2. Remove the balloon catheter and confirm the result with angiography.
NOTE: Diameter of the stent may be increased after placement by expanding with a larger diameter balloon. Do
not exceed the maximum recommended expanded stent diameter of 24mm for the 8 zig stents, and 30mm for
the 10 zig stents.
RETURN OF EXPLANTED DEVICE:
NuMED, Inc. is interested in obtaining recovered CP Stents. Place the explanted device in a container or vial
immediately after excision. For further instructions on the return of an explanted device, contact RA Manager,
NuMED, Inc. 2880 Main Street, Hopkinton, New York, 12965. Phone number: 315-328-4491.
WARNING: NuMED stents are placed in the extremely hostile environment of the human body. Stents may fail to
function for a variety of causes including, but not limited to, medical complications or failure of stent by fracture
and embolization. In addition, despite the exercise of all due care in design, component selection, manufacture,
and testing prior to sale, stents may be easily damaged before, during, or after insertion by improper handling,
crimping or other intervening acts. Metal stents placed where there are extrinsic forces of compression, i.e. right
ventricular outflow tract, are especially prone to fatigue fracture and embolization and should be avoided.
Stents and accessories are sold in an 'as is' condition. The entire risk as to the quality and performance of the
stent is with the buyer. NuMED disclaims all warranties, expressed or implied, with respect to catheters and
accessories, including but not limited to, any implied warranty of merchantability or fitness for a particular
purpose. NuMED shall not be liable to any person for any medical expenses or any direct or consequential
damages resulting from the use of any catheter or accessory or caused by any defect, failure, or malfunction of
any catheter or accessory, whether a claim for such damages is based upon warranty, contract, tort, or
otherwise. No person has any authority to bind NuMED to any representation or warranty with respect to
catheters and accessories.
Inflated (Stent length
Balloon after expansion)
Diameter Percentage
Shortening
(1.61) cm
12mm
(1.54) cm
14mm
(1.51) cm
15mm
(1.48) cm
16mm
(1.43) cm
18mm
(1.32) cm
20mm
(1.23) cm
22mm
(1.05) cm
24mm
Warranty and Limitations
CP Stent
CP8Z16 CP8Z22
(Stent length
after expansion)
Percentage
Shortening
(2.18) cm
2.8% 0.8%
(2.08) cm
6.5% 5.4%
(2.02) cm
8.5% 7.9%
(1.98) cm
10.6% 10.1%
(1.89) cm
13.7% 14.0%
(1.80) cm
20.0% 17.9%
(1.67) cm
25.4% 23.9%
(1.46) cm
36.4% 33.8%
Foreshortening Chart
®
CP8Z28
(Stent length
after expansion)
Percentage
Shortening
(2.62) cm
4.4%
(2.56) cm
6.8%
(2.51) cm
8.6%
(2.45) cm
10.7%
(2.38) cm
13.3%
(2.30) cm
16.3%
(2.09) cm
24.0%
(1.91) cm
30.3%
4
CP8Z34
(Stent length (Stent length
after expansion) after expansion)
Percentage Percentage
Shortening Shortening
(3.23) cm (3.72) cm
3.1%
(3.15) cm (3.66) cm
5.4%
(3.10) cm (3.54) cm
7.0%
(3.00) cm (3.48) cm
9.8%
(2.88) cm (3.20) cm
13.5%
(2.63) cm (2.96) cm
20.9%
(2.46) cm (2.85) cm
26.0%
(2.07) cm (2.27) cm
37.9%
CP8Z39
1.9%
3.6%
6.6%
8.2%
15.6%
21.9%
25.0%
40.1%