Vantris, a biocompatible, synthetic, non-biodegradable, easy-to-inject bulking substance. Evaluation of local tissular reaction, localized migration and long-distance migration.

Biodegradable injectable bulking agents of animal origin present a fast rate of bio-reabsorption and may cause an allergic reaction. Biodegradable elements of synthetic origin have a high rate of reabsorption after a year. Non-biodegradable agents of synthetic origin lead to the formation of a fibrotic capsule, giving stability and long-term permanence. VANTRIS is categorized into this last group; it belongs to the family of Acrylics, particles of polyacrylate polyalcohol copolymer immersed in a glycerol and physiological solution carrier. Molecular mass is very high. When injected in soft tissues, this material causes a bulkiness that remains stable through time. The carrier is a 40% glycerol solution with a pH of 6. Once injected, the carrier is eliminated by the reticular system through the kidneys, without metabolizing. Particles of this polyacrylate polyalcohol with glycerol are highly deformable by compression, and may be injected using a 23-gauge needle. The average of particles size is 320 mm. Once implanted, particles are covered by a fibrotic capsule of up to 70 microns. Particles of this new material are anionic with high superficial electronegativity, thus promoting a low cellular interaction and low fibrotic growth. The new polyacrylate polyalcohol copolymer with glycerol was tested for biocompatibility according to ISO 10993-1:2003 in vitro, showing that they are not mutagenic for the Salmonella T. strains analyzed. The extract turned out to be non-cytotoxic for cell lines in culture and non-genotoxic for mice. In in vivo studies, acrylate did not cause sensitization in mice. The macroscopic reaction of tissue irritation was not significant in subcutaneous implants and in urethras of rabbits. Seven female dogs were injected transurethrally with VANTRIS to evaluate short and long-term migration (13 weeks and 12 months respectively). No particles or signs of inflammation or necrosis are observed in any of the organs examined 13 weeks and 12 months after implantation. To conclude, this new material meets the conditions of ideal tissue bulking material.

Vantris®, a biocompatible, synthetic, non-biodegradable, easy-to-onject bulking substance. Evaluation of local tissular reaction, localized migration and long-distance migration / Vantris® una sustancia inyectable biocompatible, sintética, no biodegradable y fácil de aplicar: Evaluación de la reacción tisular local, y de la migración local y a larga distancia

Biodegradable injectable bulking agents of animal origin present a fast rate of bio-reabsorption and may cause an allergic reaction. Biodegradable elements of synthetic origin have a high rate of reabsorption after a year. Non-biodegradable agents of synthetic origin lead to the formation of a fibrotic capsule, giving stability and long-term permanence. VANTRIS® is categorized into this last group; it belongs to the family of Acrylics, particles of polyacrylate polyalcohol copolymer immersed in a glycerol and physiological solution carrier. Molecular mass is very high. When injected in soft tissues, this material causes a bulkiness that remains stable through time. The carrier is a 40% glycerol solution with a pH of 6. Once injected, the carrier is eliminated by the reticular system through the kidneys, without metabolizing. Particles of this polyacrylate polyalcohol with glycerol are highly deformable by compression, and may be injected using a 23-gauge needle. The average of particles size is 320 mm. Once implanted, particles are covered by a fibrotic capsule of up to 70 microns. Particles of this new material are anionic with high superficial electronegativity, thus promoting a low cellular interaction and low fibrotic growth. The new polyacrylate polyalcohol copolymer with glycerol was tested for biocompatibility according to ISO 10993-1:2003 in vitro, showing that they are not mutagenic for the Salmonella T. strains analyzed. The extract turned out to be non-cytotoxic for cell lines in culture and non-genotoxic for mice. In in vivo studies, acrylate did not cause sensitization in mice. The macroscopic reaction of tissue irritation was not significant in subcutaneous implants and in urethras of rabbits. Seven female dogs were injected transurethrally with VANTRIS® to evaluate short and long-term migration (13 weeks and 12 months respectively). No particles or signs of inflammation or necrosis are observed in any of the organs examined 13 weeks and 12 months after implantation. To conclude, this new material meets the conditions of ideal tissue bulking material (AU)

Los agentes inyectables biodegradables de origen animal presentan una tasa rápida de bioreabsorción y pueden provocar reacciones alérgicas. Los elementos biodegradables de origen sintético tienen una alta tasa de reabsorción después de un año. Los agentes no-biodegradables de origen sintético dan lugar a la formación de una cápsula fibrótica, dando estabilidad y permanencia a largo plazo. VANTRIS® se clasifica en este último grupo; pertenece a la familia de los acrílicos, partículas de copolímero poliacrida polialcohol inmersas en una solución vehiculante de glicerol y fisiológico. Su masa molecular es muy alta. Cuando se inyecta en tejidos blandos, este material produce un abultamiento que permanece estable a lo largo del tiempo. El vehículo contiene un 40% de solución de glicerol con un pH de 6. Una vez inyectada, el vehículo es eliminado por el sistema reticular a través de los riñones, sin metabólizar. Las partículas de este poliacrilato polialcohol con glicerol son altamente deformables por compresión, y pueden inyectarse utilizando una aguja del 23 Gauge. El tamaño medio de las partículas es de 320 mm. Una vez implantadas, las partículas se recubren de una cápsula fibrótica de hasta 70 micrones. Las partículas de este nuevo material son aniónicas y tienen una gran electronegatividad en superficie, promoviendo así una baja interacción celular y un bajo crecimiento fibrótico. El nuevo copolímero de poliacrilato polialcohol con glicerol fue sometido a pruebas de biocompatibilidad in vitro de acuerdo con la normal ISO 10993-1:2003, mostrando que no es mutagénico para las cepas de salmonela T. analizadas. El extracto no fue citotóxico en cultivos de líneas celulares ni en ratones. En los estudios in vivo, el acrilato no produjo sensibilización en ratones. Los implantes subcutáneos y en uretra de conejos no produjeron reacción de irritación tisular macroscópica significativa. Para evaluar la migración a corto y largo plazo se inyectó Vantris® por vía transuretral en siete hembras de perro (13 semanas y 12 meses respectivamente). No se observaron partículas o signos de inflamación con necrosis en ninguno de los órganos examinados ni a las 13 semanas ni a las 12 meses del implante. En conclusión, este nuevo material cumple con las condiciones del material inyectable tisular ideal