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Viscoll®Collagen membrane for corneal repair

The status of a medical product
Clinical trials of the medical device are underway

Medical product description

The product is a homogeneous, rounded, transparent collagen plate made from highly purified native type I collagen isolated from porcine tendons. The product is intended to replace the surface of the eye through surgical intervention. The product can be used for anterior layer-by-layer and reinforcing keratoplasty for treatment of corneal leukoma and ulcers of various etiologies, pterygium, as well as for surgical treatment of traumatic injuries of the eyeball. And also to use as a temporary keratoprosthesis for surgical manipulations in the absence of corneal transparency.

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Mechanism of action

The product functions as a natural extracellular matrix, which is necessary for the normal healing of damaged corneas and restoring their anatomic and functional characteristics using the body's own regenerative potential. After implantation into the stroma, the implant is filled with the cornea's own cells, which begin to actively interact with it, gradually replacing it with its own stromal tissue.

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The key characteristics of a medical device

Biocompatibility, low immunogenicity and non-toxicity.

Viscoll® collagen extracted from healthy animal tissues is used to manufacture the Product. Obtaining the extract as a true solution (not a suspension) of native (not denatured) protein provides complete biochemical purification of collagen from potentially immunogenic impurities, which is controlled by appropriate immunological testing. Viscoll® collagen preparations are obtained sterile, apirogenic, completely bioresorbable and irritation-free at implantation, neither in the short nor in the long term.

Transparency

The developed technology allows to create optically transparent collagen membranes, which retain their transparency when implanted into the corneal stroma.

Durability

The product possesses sufficient mechanical properties to perform standard surgical manipulations, for fixation in the place of implantation with a standard surgical suture using 10/0 or 8/0 thread.

Sterility

The product is sterile by aseptic production process.

In vivo safety and efficacy studies of the medical device involving laboratory animals.
Publications in peer-reviewed scientific journals.
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In vivo safety and efficacy studies of the medical device involving laboratory animals

Publications in peer-reviewed scientific journals

Authors
Yu Y, Andreev AY, Rogovaya OS, Subbot AM, Domogatsky SP, Avetisov SE, Vorotelyak EA, Osidak EO
Title
Matrix-Assisted Cell Transplantation for the Treatment of Limbal Stem Cell Deficiency in a Rabbit Model
Year
2024
Journal
Biomedicines
DOI/URL
Authors
Andreev AY, Yusef YN, Avetisov SE, Osipyan GA, Domogatsky SP, Osidak EO
Title
Collagen-Based Artificial Cornea for Lamellar Keratoplasty: An Early Case Report
Year
2024
Journal
Cornea
DOI/URL
Authors
Osidak EO, Andreev AY, Avetisov SE, Voronin GV, Surnina ZV, Zhuravleva AV, Grigoriev TE, Krasheninnikov SV, Sukhinich KK, Zayratyants OV, Domogatsky SP
Title
Corneal Stroma Regeneration with Collagen-Based Hydrogel as an Artificial Stroma Equivalent: A Comprehensive In Vivo Study
Year
2022
Journal
Polymers
DOI/URL
Authors
Andreev AY, Osidak EO, Grigoriev TE, Krasheninnikov SV, Zaharov VD, Zaraitianc OV, Borzenok SA, Domogatsky SP
Title
A new collagen scaffold for the improvement of corneal biomechanical properties in a rabbit model
Year
2021
Journal
Experimental Eye Research
DOI/URL