2. 2
Introduction
The Tan EndoGlideā¢ is a disposable medical device designed to
facilitate insertion of the donor endothelium during a DSEK /
DSAEK surgery. Descemet's stripping endothelial keratoplasty
(DSEK) or Descemet's stripping automated endothelial keratoplasty
(DSAEK) are terms for corneal transplantation techniques that
replace only the posterior diseased cornea.
The product is packaged sterile,
one (1) unit per box. Each unit
consists of a preparation base,
glide cartridge and
glide introducer.
Ref item # 11820
3. 3
Tan Forceps
Re-usable titanium forceps designed for use with the Tan
EndoGlideā¢ are sold separately.
The straight Tan EndoGlideā¢ Loading Forceps loads the donor
cornea into the glide cartridge. Ref item # 53-952
The curved Tan EndoGlideā¢ Placement Forceps glides the donor
cornea from the cartridge into the anterior chamber for
positioning.
Ref item # 53-951
4. 4
How to use the Tan EndoGlideā¢
(Step 1)
Both anterior and posterior
lenticules of the donor are first
placed endothelium up, into the
donor well of the preparation
base.
A small amount of dispersive
viscoelastic is applied to the
endothelial surface in a thin strip.
Note: Always refer to the package insert
provided with the product for complete
instructions for use, indications,
precautions, contraindications and
warnings.
5. 5
How to use the Tan EndoGlideā¢
(Step 2)
The Tan EndoGlideā¢ cartridge is
designed to fit through a 4.5mm
incision, and to accommodate a
donor lenticule measuring up to
9.5mm in diameter and 250
microns in thickness.
The Tan EndoGlideā¢ cartridge is
supplied in the preparation base
and some BSS is injected for
lubrication.
The Tan EndoGlideā¢ loading
forceps are introduced through
the cartridge, to grasp the stromal
edge of the posterior donor
lenticule.
6. 6
How to use the Tan EndoGlideā¢
(Step 3)
Pulling the lenticule into the cartridge
automatically curls the donor into a
double helix configuration, with no
endothelial surfaces touching.
Symmetrical coiling may be facilitated
with a sinskey hook or BSS cannula.
Remove the donor anterior lenticule
from the well of the Preparation Base
and discard.
The Tan EndoGlideā¢ introducer is
attached to the cartridge, sealing the
back end of the capsule.
The assembled Tan EndoGlideā¢ is
removed from the base, rotated 180
degrees, and is ready for insertion.
7. 7
How to use the Tan EndoGlideā¢
(Step 4)
An AC maintainer is recommended
to stabilize the chamber.
The Tan EndoGlideā¢ is carefully
inserted through a scleral tunnel
incision, forming a complete seal
of the wound.
Tan EndoGlideā¢ Placement
Forceps, introduced through the
nasal paracentesis, simply grasps
the stromal leading edge of the
donor and glides it completely into
the anterior chamber.
8. 8
How to use the Tan EndoGlideā¢
(Step 5)
Gentle manipulation of the
donor with forceps, coupled
with the deep anterior
chamber enables uncurling of
the donor without risk of donor
inversion.
The Tan EndoGlideā¢
Placement Forceps hold the
donor in the anterior chamber
until the EndoGlideā¢ has been
withdrawn.
9. 9
How to use the Tan EndoGlideā¢
(Step 6)
The Tan EndoGlideā¢ is
removed.
A small air bubble is injected
beneath the donor to prevent
descent onto the iris.
The donor is released and the
Tan EndoGlideā¢ Placement
Forceps is withdrawn.
10. 10
Tan EndoGlideā¢
Designed to minimize cell loss
- ādouble curlingā of donor
- Tan EndoGlideā¢ Placement
Forceps grips stromal edge only
Stable AC throughout
- closed eye procedure
Full donor control at all times
- Tan EndoGlideā¢ Placement
Forceps holds donor in the AC even
after Tan EndoGlideā¢ is withdrawn
Advantages of the Tan EndoGlideā¢
13. 13
DSEK / DSAEK Coding Basics
DSEK / DSAEK is indicated when medically necessary for corneal
endothelial dysfunction, including (but not limited to):
Condition ICD-9-CM
Fuchsā dystrophy 371.57
Bullous keratopathy 371.23
DSEK / DSAEK is billed using the following code:
Procedure CPT Code
Keratoplasty (Corneal transplant); Endothelial 65756
14. 14
Tan EndoGlideā¢
SNEC Tan EndoGlideā¢ Clinical Trial
Preliminary Results (n=26)
IRB approved clinical trial - 100 eyes
30 eyes performed to date in 30 patients
Mean age: 70 yrs (range 28-91yrs)
Diagnoses:
ABK/PBK (n=14) Fuchs Dystrophy (n=12)
Others (n=4)
Procedures:
DSAEK: 19 Phaco-DSAEK: 11
Mean donor diameter: 8.75mm
(range 8.0-9.5mm)
Follow-up period: all with at least 1 month
follow-up, 20 with 3 months, 17 with 6 months
and 5 with 1 year follow-up)
Singapore National Eye Center (SNEC)
Surgeon: Professor Donald T.H. Tan
Data reported April 2010 in results during the AAO, and the data also has
been submitted for publication (American Journal of Ophthalmology).
15. 15
Contact Information
Distribution in North America:
Surgical Specialties Corporation (dba Angiotech)
100 Dennis Drive
Reading, PA 19606
Customer Care Center: (877) 991-1110 or (732) 626-6466
www.sharpoint.com
www.angioedupro.com