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 EverPatch Advantages
Inert and non-degradable material –
Bio-mechanical integration coupled with a minor and progressively subsiding, inflammatory response
Extremely easy to handle and suture
Elastic and durable (cannot be torn by the sutures)
Synthetic and therefore cannot carry or transmit disease
Thin (100 microns), minimizing risk of dellen
Reduces operating time and eye bank costs
Eliminates complexities related to the transportation and storage of biological materials
Readily available, off-the-shelf, device
Translucent when wet
Hardly visible when implanted
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.
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
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.
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.