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

ABSTRACT

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.