1 © 2010 Angiotech Pharmaceuticals, Inc. © 2010 Surgical Specialties Corporation. All Rights Reserved. Tan EndoGlide™ is a trademark of Coronet Medical Technologies Ltd. No reproduction or duplication of any portion of this work shall be made without prior written permission of the authors. OPG-PM-386 08/10 Product Introduction
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© 2010 Angiotech Pharmaceuticals, Inc. © 2010 Surgical Specialties Corporation. All Rights Reserved. Tan EndoGlide™ is a trademark of Coronet Medical Technologies Ltd.No reproduction or duplication of any portion of this work shall be made without prior written permission of the authors. OPG-PM-386 08/10
Product Introduction
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Introduction
The Tan EndoGlide™ 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 unitconsists of a preparation base,glide cartridge andglide introducer.
Ref item # 11820
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Tan Forceps
Re-usable titanium forceps designed for use with the Tan EndoGlide™ are sold separately.
The straight Tan EndoGlide™ Loading Forceps loads the donor cornea into the glide cartridge. Ref item # 53-952
The curved Tan EndoGlide™ Placement Forceps glides the donor cornea from the cartridge into the anterior chamber for positioning.Ref item # 53-951
4How to use the Tan EndoGlide™(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.
5How to use the Tan EndoGlide™(Step 2)
The Tan EndoGlide™ 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 EndoGlide™ cartridge is supplied in the preparation base and some BSS is injected for lubrication.
The Tan EndoGlide™ loading forceps are introduced through the cartridge, to grasp the stromal edge of the posterior donor lenticule.
6How to use the Tan EndoGlide™(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 EndoGlide™ introducer is attached to the cartridge, sealing the back end of the capsule.
The assembled Tan EndoGlide™ is removed from the base, rotated 180 degrees, and is ready for insertion.
7How to use the Tan EndoGlide™(Step 4)
An AC maintainer is recommended to stabilize the chamber.
The Tan EndoGlide™ is carefully inserted through a scleral tunnel incision, forming a complete seal of the wound.
Tan EndoGlide™ Placement Forceps, introduced through the nasal paracentesis, simply grasps the stromal leading edge of the donor and glides it completely into the anterior chamber.
8How to use the Tan EndoGlide™(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 EndoGlide™Placement Forceps hold the donor in the anterior chamber until the EndoGlide™ has been withdrawn.
9How to use the Tan EndoGlide™(Step 6)
The Tan EndoGlide™ is removed.
A small air bubble is injected beneath the donor to prevent descent onto the iris.
The donor is released and the Tan EndoGlide™ Placement Forceps is withdrawn.
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Tan EndoGlide™
Designed to minimize cell loss- “double curling” of donor- Tan EndoGlide™ Placement Forceps grips stromal edge only
Stable AC throughout- closed eye procedure
Full donor control at all times- Tan EndoGlide™ Placement Forceps holds donor in the AC even after Tan EndoGlide™ is withdrawn
Advantages of the Tan EndoGlide™
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Regulatory Status
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Regulatory Status
Letter from Tan EndoGlide Supplier
Product is CE marked in Europe
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DSEK / DSAEK Coding Basics
DSEK / DSAEK is indicated when medically necessary for corneal endothelial dysfunction, including (but not limited to):
Condition ICD-9-CMFuchs’ dystrophy 371.57Bullous keratopathy 371.23
DSEK / DSAEK is billed using the following code:
Procedure CPT CodeKeratoplasty (Corneal transplant); Endothelial 65756
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Tan EndoGlide™
SNEC Tan EndoGlide™ 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. TanData reported April 2010 in results during the AAO, and the data also has been submitted for publication (American Journal of Ophthalmology).
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Contact Information
Distribution in North America:
Surgical Specialties Corporation (dba Angiotech)100 Dennis DriveReading, PA 19606
Customer Care Center: (877) 991-1110 or (732) 626-6466
www.sharpoint.com
www.angioedupro.com
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