The status of a medical product
Toxicological trials of the medical device are underway
The product is a soft, pliable, rounded, porous white matrix made of highly purified native type I collagen isolated from porcine tendons. The product is intended for use in surgical procedures that require replacement or repair of the patient’s dura mater.
The product acts as a natural extracellular matrix, which is necessary for the normal healing of damaged dura mater using the body's own regenerative potential. The implant is resorbed and replaced by the patient's own tissue within 3-6 months.
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.
Clear retention of the membrane after application to the affected dura following animal experiments, and prevents the development of cerebrospinal fluid.
Membrane is permeable to cells both in vitro and in vivo.
Human cell culture can be pre-cultured on both surfaces of the product.
Publications in peer-reviewed scientific journals
