Device Description; Indications For Use - New World Medical AHMED ClearPath CP250 Manual Del Usuario

4.
The AHMED
The AHMED ClearPath glaucoma drainage device is a non-valved drainage device designed to shunt
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aqueous in eyes suffering from refractory glaucoma. The implant consists of a medical grade silicone tube
secured near the anterior suture points of the medical grade silicone episcleral plate. Two models are
available that cover surface areas of approximately 250 mm
located on the anterior side of the plate, flanking each side of the tubing track. The silicone plate is barium
impregnated to increase ultrasound resolution and identification with CT scans, MRIs and plain skull films.
The plate conforms to the shape of the globe at its equator and provides a surface from which fluid can be
dispersed. The device is for single use only.
Each AHMED ClearPath glaucoma drainage device is supplied with a 23-gauge hypodermic needle and a
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4-inch 4-0 polypropylene ripcord, for optional use, in a sterile, sealed double-pouch. The use or non-use of
both the 23-gauge hypodermic needle and/or the ripcord do not alter the standard care for the implantation
of the AHMED ClearPath glaucoma drainage device.
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Model CP250
Model Surface
Area*
CP250 250 mm
CP350 350 mm
* Surface area does not include the area covered by the suture arms.
The AHMED ClearPath glaucoma drainage devices are indicated for the management of refractory
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glaucoma where previous surgical treatment has failed or is not expected to provide satisfactory results.
Such refractory glaucoma may include but is not limited to: neovascular glaucoma, congenital or infantile
glaucoma, and refractory glaucoma resulting from aphakia or uveitis.
ClearPath Glaucoma Drainage Device
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Device Description:

Top View
Side View
Plate
Length Width (Max)
16 .70 mm
2
16 .48 mm
2

Indications for Use:

and 350 mm
2
Suture Arm
Suture Arm
Suture Arm
Plate Plate
Thickness
(Max)
18 .47 mm 0 .86 mm
30 .47 mm 0 .86 mm
. The anterior suture points are
2
Model CP350
Top View
Suture Arm
Suture Arm
Side View
Suture Arm
Tube Tube ID
Length
32 mm 0 .305 mm
32 mm 0 .305 mm
Tube OD
0 .635 mm
0 .635 mm