REDUCTION OF THE RISK OF INFECTION AND PREVENTION OF DEVICE
MIGRATION

BIOLOGICAL ENVELOPE bioNEST
Biological envelope bioNEST
Dimensions
Lower infection rate
The porous structure of the envelope material makes it possible to impregnate it with medicine (for example, with antibiotics) prior to implantation, thus reducing the risk of postoperative infectious complications.

Migration prevention
The product securely holds under the skin without the risk of migration, bed sores and fistulas.

Natural raw material
Components of the envelope are made of highly purified biocompatible collagen material of xenogenic origin.

Hemostatic properties
The hemostatic properties of natural collagen are complemented by the effective action of aminocaproic acid impregnated into the product.

Atraumatic
The natural material of the envelope and resorbable suture material from polyglycolic acid do not injure the surrounding tissues and do not cause adverse reactions in the patient’s tissues.

Wide range
The size range of the envelope makes it possible to work with practically all models of CIEDs.

Formed capsule
Active components contained in the material stimulate the processes of revascularization and biointegration, contributing to the formation of healthy surrounding tissues without adhesions to the leads, facilitating reimplantation.
Indications for use
• prevention of the CIED migration after implantation
• prevention of bed sores at the CIED bed
• prevention of infectious diseases (providing the medicine is additionally administered)
Indications for the use of the product are determined by the healthcare professional in accordance with the established diagnostic and treatment procedures.

Contraindications
• individual intolerance to the components that make up the product.

Use with special precautions in patients of the categories below:
• underaged patients (up to 18 years old)
• pregnant and breastfeeding women.

What is bioNEST made of?
pSIS
The raw material for the production of the envelope is a highly purified extracellular collagen matrix of xenogenic origin based on small intestine submucosa. The extracellular collagen matrix (ECM) is a natural biological matrix for cell colonization that acts as a scaffold from collagen and elastin, and surrounds cells in various tissues of animals. ECM regulates cell adhesion, differentiation, proliferation, and migration. ECM has the necessary biocompatible properties and consists of fibrillar proteins (mainly type I collagen and elastin), which provide resilient and durable architectonics. ECM also contains active biological molecules that give the product bioactive properties. Glycoproteins (fibronectin and laminin) promote cell adhesion and proliferation. Glycosaminoglycans (hyaluronic acid and chondroitin sulfate A) reduce inflammation. Proteoglycans (decorin and heparan sulfate) prevent the formation of scar tissue, participate in the fibrillar regulation of collagen, and stimulate angiogenesis.


Surgical thread
Resorbable suture from polyglycolic acid


Aminocaproic acid
(0.05±0.02)g per 1g of envelope

The patented multi-stage technology of chemical and biological processing of raw materials makes it possible to completely remove cellular elements, while preserving the natural architectonics of fibrillar proteins and the presence of biological molecules. Collagen, together with aminocaproic acid, inhibits fibrinolysis, which initiates hemostasis up to the formation of a fibrin clot during a surgical operation. After the operation, the fibrin clot serves as a matrix for the integration of the recipient’s tissues into the envelope wall.


Proven safety
“Cultivation of diploid human fibroblasts and mesenchymal stromal cells of human bone marrow on the surface of biomaterial samples for 24 and 96 hours showed no signs cytotoxicity. The number of dead cells during cultivation on experimental samples did not significantly differ from that during cultivation on culture dishes (spontaneous cell death) and was within 3±2 and 4±2% of the total number of cells. Mitotic activity was studied 48 and 72 hours after the start of cell cultivation on samples of the membrane (reference sample) and biomaterial (experimental sample). The highest mitotic activity of both cell types was shown during cultivation on experimental samples: the mitotic index of cells was significantly higher (p<0.05) than in the reference sample. The dynamics of the number of cell populations was determined by recording the number of cells that grew on the surface of the membrane samples (reference) and biomaterial (experimental) every 24 hours for 7 days of cultivation. The greatest increase in the number of both types of cells was shown when cultivating on experimental samples compared to the reference (p<0.05). Thus, the studied samples of the envelope biomaterial are non-toxic, biocompatible and are a suitable substrate for attachment, growth and reproduction of stem cells.”
D.V. Shadrina.

Evaluation of biocompatibility and local action of a biomaterial for the production of an envelope for implantable cardiac electronic devices / D.V. Shadrina, A.A. Venediktov, S.V. Evdokimov, V.A. Vaskovskiy, E.A. Artyukhina, A.S. Revishvili, S.S. Durmanov, V.V. Bazylev // Bulletin of Experimental Biology and Medicine. – 2019. – V. 168, No. 9

Results of orthotopic implantation
Orthotopic implantation was carried out on adult domestic pigs (Sus domesticus). The animals were kept in an animal facility according to the requirements of GOST 10993-2. At implantation, we carried out an assessment of a pacemaker retention with the envelope bioNEST and without it. The risk of infective endocarditis was also modeled during the operation. A skin incision was made in the chest area. A bed was formed between subcutaneous adipose tissue and muscle tissue. The implantation site was treated with alcohol and AHD 2000-express solution. The preliminary prepared experimental sample was placed in the formed bed so that the lead lay under the CIED. The wound was treated with 3% hydrogen peroxide solution and sutured with surgical threads of MedEng “Medlavsan 2/26”. The suture site was covered with a bandage.



Histological examination of the tissue after three months of implantation in the area of ​​contact between the envelope and the CIED showed proliferation of connective tissue with a thickness of no more than 10μm. There was no inflammatory response. At some distance from the edge of contact with the pacemaker, active processes of neoangiogenesis were noted, in the form of a group of newly formed vessels (the intensity of blood vessel formation is the most pronounced in comparison with other samples). The border between the fabric of the envelope and the recipient’s tissues was indistinct. Encapsulation phenomena were weakly expressed. Active processes of biointegration of the recipient’s connective tissue were also revealed (90-100%).


1. Bazylev V.V. Evaluation of the local action of the biological envelope in the model of the infected bed of the pacemaker in the experiment on a large laboratory animal / V.V. Bazylev, N.V. Makarova, S.S. Durmanov and others // Annals of arrhythmology. - 2019. - V. 16, No. 4. - p. 240–250.
2. Artyukhina E.A. Evaluation of the performane of a biological envelope for implantable cardiac devices impregnated with bioactive substances in an experiment on large laboratory animals / E.A. Artyukhina, V.A. Vaskovsky, A.A. Venediktov and others // Siberian Medical Journal. - 2019. - No. 34 (2). - p. 118-128.

Physical and mechanical properties
The “bioNEST” envelope has the necessary physical and mechanical characteristics. We routinely carry out studies on the INSTRON-5944 BIO PULS testing machine, which consistently confirm the declared stress-strain performance. The internal fibrous structure provides high resistance to cutting by surgical sutures.