About Ophthalmic Reconstructive Surgery
Reconstructive surgery of the eye takes place following irreparable damage to the eye’s integrity. Such damage can result following trauma, iatrogenic damage (damage caused unintentionally during a surgical procedure) or as a result of an inflammatory/connective tissue disease process. In these instances, the tissue can incur such damage that direct and immediate closure becomes impossible making patching the area with preserved and processed tissue the only treatment option.
CorNeat KPro
CorNeat EverPatch Advantages
Everlasting
Inert and non-degradable material
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Bio-mechanical integration coupled with a minor and progressively subsiding, inflammatory response
Ease of
Handling
Extremely easy to handle and suture
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Elastic and durable (cannot be torn by the sutures)
Safe
Synthetic and therefore cannot carry or transmit disease
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Biocompatible
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Thin (100 microns), minimizing risk of dellen
Cost-Effective
Reduces operating time and eye bank costs
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Eliminates complexities related to the transportation and storage of biological materials
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Readily available, off-the-shelf, device
Aesthetic
Translucent when wet
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Hardly visible when implanted subconjunctivally
CorNeat EverPatch
The CorNeat EverPatch (scleral patch) is the first inert, synthetic and nondegradable tissue substitute for use in ophthalmic surgeries. The CorNeat EverPatch replaces the use of human tissue and degradable collagen patches for covering and concealing implants such as glaucoma drainage devices and sealing the eye in cases of missing tissue.
The CorNeat EverPatch is composed of a non-woven, polymer matrix, which imitates the extracellular matrix, stimulating cellular colonization and integration with the surrounding tissue.
Indications
Reinforcing the sclera and aiding the physical reconstruction of the ocular surface
Concealing irritating ophthalmic implants such as glaucoma tube shunts and scleral sutures, used in scleral fixations of IOLs, displacing the need for preserved tissue/collagen
Covering tissue gaps/weaknesses, resulting from either traumatic, disease related or iatrogenic damage
First-In-Human (FIH) Implantation
The FIH implantation of the initial CorNeat EverPatch took place in December 2020 as part of a bilateral glaucoma tube shunt implantation. The surgery was conducted by Dr. Ike Ahmed at the Prism Eye Institute in Toronto, Canada.
The fact this patient underwent the same surgery in both eyes at the same time by the same surgeon presents a unique opportunity to compare the CorNeat EverPatch and current state of the art (scleral patch) – both used to conceal the shunt and protect the overlaying conjunctival tissue.
Below on the right, you can see the eye implanted with the scleral patch and on the left, the eye implanted with the CorNeat EverPatch, both photos were taken two months post-implantation.
Besides the clear aesthetic advantages of the CorNeat EverPatch over the scleral (tissue) patch, the device's clinical advantages are very clear. While the conjunctival tissue overlaying the CorNeat EverPatch is healthy and quiet, congestion and inflammation is clearly visible over the scleral patch – an expected reaction to donor tissue.
28 patients were implanted with the initial configuration of the CorNeat EverPatch with promising results, thus completing the FIH clinical trial.
For more information about the FIH clinical trial click here.
Pivotal Trial
A pivotal trial for evaluating the performance of the final product is currently underway in Tbilisi, Georgia. This pivotal trial already has 12 patients implanted with the improved CorNeat EverPatch, without any safety issues. Further sites are currently being evaluated.
Immediately post-op, the CorNeat EverPatch is visible under the conjunctiva (in two different patients):
For more information about the pivotal trial click here.
Regulatory Path
FDA Clearance
The CorNeat EverPatch is following a 510(k) clearance path, after submitting all necessary documents to the FDA in September 2022. The 510(k) submission is based on numerous tests and assessments which include a long-term animal trial, usability assessment and numerous R&D tests. The device is expected to be approved for marketing in the US and in FDA adopting countries early in 2023, with the following intended use: implantation to reinforce the sclera and aid the physical reconstruction of the ocular surface.
CE Marking
The current pivotal trial is geared toward obtaining a CE Marking early in 2024, for wider indications that include: the concealment of artificial ophthalmic implants, such as glaucoma shunts and scleral sutures used in scleral fixations of IOLs, from the overlying conjunctiva.
The plans above are subject to regulatory approvals and requirements.