Assessment of Biocompatibility and Local Action of Biomaterial for Production of an Envelope for Implanted Heart Electronic Devices

• Published in: Bulletin of experimental biology and medicine Vol. 168; no. 3; pp. 375 - 377
• Main Authors: Shadrina, D. V., Venediktov, A. A., Evdokimov, S. V., Vaskovskii, V. A., Artyukhina, E. A., Revishvili, A. Sh, Durmanov, S. S., Bazylev, V. V.
• Format: Journal Article
• Language: English
• Published: New York Springer US 2020; Springer
• Subjects: Biological products; Biomedical and Life Sciences; Biomedicine; Cell Biology; Collagen; Implants, Artificial; Internal Medicine; Laboratory Medicine; Pathology; Prosthesis; Raw materials; Stem cells; extracellular collagen matrix; cardiac implantable electronic devices; cytotoxicity
• ISSN: 0007-4888; 1573-8221
• DOI: 10.1007/s10517-020-04712-0

We studied a biomaterial for a new domestic product, a biological envelope for implantation of cardiac electronic devices. The product is designed to prevent complications after pacemaker implantation and to facilitate the reimplantation procedure. By chemical and biological processing of raw materials (submucosa of porcine small intestine), an acellular extracellular collagen matrix was obtained. The biocompatibility of the material was tested
in vitro
using stem cell cultures. The biomaterial for fabrication of the envelope is not cytotoxic, biocompatible, and represents a suitable substrate for attachment, growth, and reproduction of stem cells. The biological effect of the material was studied
in vivo
on the model of heterotopic implantation in small laboratory animals. The biomaterial did not induce inflammation and tissue reaction and was completely transformed into healthy vascularized tissue without scars in 90 days after implantation.