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 –
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 either from traumatic, disease related or iatrogenic damage
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.
For more information about the FIH clinical trial click here, for more information about the pivotal trial click here.