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Clinical Development

Known for our Process and Product Innovation

  • Preloaded DSAEK in the EndoGlide – 2012
  • No-touch DMEK hydro-dissection technique – 2012
  • Nano-Cut DSAEK grafts 40-70 microns – 2014
  • Preloaded DMEK Jones Tube – 2015
  • Preloaded DMEK in a LEITR 2.0 – 2018
  • Preloaded DMEK in EndoGlide – 2019
  • Preloaded DSAEK in LEITR 3.0 – 2020
  • OptiGraft – Sterile Ophthalmic Allografts – 2020

First Eye Bank to Distribute Preloaded Tissue

In 2012, LEITR’s clinical development team introduced the first preloaded corneal graft. Preloaded DSAEK grafts in an EndoGlide were developed through the collaboration and support of many ophthalmologists, specifically Dr. Kathryn Colby. Today LEITR offers more options to choose from for both DSAEK and DMEK grafts.

Preloaded tissue reduces the surgical time of my cases, and I don’t have the stress of having to trephine and load my own tissue.
– Kathryn A. Colby, M.D.

Blister Method

No-touch DMEK/PDEK graft separation using hydrodissection technique

Optisol GS is used to create the initial separation of Descemet’s Membrane (DM) or Pre-Descemet’s Membrane. Trypan Blue is then introduced to complete the separation. During the process the graft is supported by fluid and the stain is isolated to the DM while the endothelium is protected.

Advantages over SCUBA

  • Tissue is not pulled or touched by forceps (no-touch)
  • Graft is supported throughout preparation (hydrodissection)
  • Selective stromal staining limits exposure to Trypan Blue
  • Specular image post-prep of endothelium provided

Having peeled close to a thousand DMEK donors with the SCUBA technique has given me a unique perspective on the tremendous advantages of the LEITR hydrodissection technique (Blister Method). I only do the LEITR Blister Method. It’s a game changer!
-Mark S. Gorovoy, MD

Abstracts

ASCRS 2018 Abstract-PDEK Blister technique
Cornea symposium 2016 -Abstract-DMEK Blister technique

Nano-Cut DSAEK grafts: 40-70 microns

High Pressurized Anterior Chamber (HPAC) Technique

Studies comparing tissue processing techniques for DSAEK show no statistical impact in endothelial cell loss between the HPAC and IV tubing method. However, the HPAC method provides several noteworthy benefits when utilized. The significant decrease in endothelial cell recovery time demonstrates less stress to endothelium, confirming this technique to be safe and less traumatic to endothelium. With repeatable control and accuracy thinner grafts (40-70 microns) are produced with less chance of perforations.

Abstracts

ASCRS 2019 – High Pressurized Anterior Chamber (HPAC) technique

TransplantREADY LEITR DMEK 2.0

  • Narrow insertion tip reduces the need for suture
  • Small incision size (2.0 – 2.2mm) allows the same incision to be used during triple procedures
  • Wide-body allows graft to be suspended in Optisol GS promoting cell preservation during transport
TransplantREADY DMEK 2.0 with 14 French tubing and 2-way valve connector

TransplantREADY LEITR DSAEK 3.0

Designed specifically for preloaded Nano-Cut DSAEK grafts, LEITR DSAEK 3.0 promotes smaller incision sizes and no-touch delivery using fluid injection.

This injector system is a revolutionary way of doing DSAEK cornea surgery, with smaller wounds and a brand new “no-touch” technique. The system delivers the cornea transplant tissue into the eye without disturbing or damaging the graft.
-Dr. Kane

OptiGraft: Sterile Ophthalmic Allografts

OptiGraft aligns well with our mission of setting new standards that transform and improve the lives of patients.

OptiGraft expands the applications and usable functionality of donated tissue, further honoring our commitment to our tissue donors and their families
– Art Kurz, Chief Clinical and Marketing Officer

Sterilizing corneal and scleral tissue using irradiation allows us to provide sight restoration to even more patients. A cornea has the potential to help one patient in need of a sight restoring corneal transplant. Through the development of OptiGraft, we are able to process a cornea that is not suitable or unable to be placed for transplant within 14 days, and provide the gift of sight to as many as four people. We are able to provide benefit to as many as 16 people with sclera tissue from one donor. In addition, offering OptiGraft has expanded our reach to include glaucoma surgeons and their patients worldwide.

Resources

OptiGraft Spec Sheet
OptiGraft_White Paper – Sterile Corneal Graft
OptiGraft_White Paper – Sterile Glaucoma Patch Graft

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