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ATRISORB®-D FreeFlow™ Barrier is indicated for the surgical treatment of periodontal defects to aid in the regeneration and integration of tissue components in guided tissue regeneration procedures. ATRISORB®-D FreeFlow™ Barrier has been shown to reduce bacterial colonization of the barrier.

The ATRISORB®-D FreeFlow™ Bioabsorbable Guided Tissue Regeneration (GTR) Barrier with 4% Doxycycline exists as a sterile, synthetic flowable polymeric solution composed of poly(DL-lactide) (PLA) dissolved in N-methyl-2-pyrrolidone (NMP). It is mixed with doxycycline hyclate prior to formation to give a 4% doxycycline concentration. The barrier precipitates to a firm consistency upon contact with water and bioabsorbs over time. One sterile unit consists of a pouched syringe with 715 mg of the ATRISORB® polymer formulation, a syringe with 35 mg doxycycline hyclate, a blunt tip cannula, and a product insert. The barrier functions by isolating the regenerative surgical site from adjacent gingival connective tissue and epithelium, facilitating population of the site with cells from the periodontal ligament and adjacent alveolar bone. The doxycycline hyclate reduces bacterial colonization of the barrier and surgical site.

ATRISORB® GTR Barrier is indicated for the surgical treatment of periodontal defects to aid in the regeneration and integration of tissue components in guided tissue regeneration procedures. ATRISORB® GTR Barrier is not intended for use in defects outside the indications statement.

The ATRISORB® polymer formulation is a sterile, synthetic flowable polymeric formulation which is bioabsorbable and has been developed for GTR procedures by Atrix Laboratories, Inc. It consists of a polymer of lactic acid, poly(DL-lactide) (PLA), dissolved in N-methyl-2-pyrrolidone (NMP). The finished device is provided in two different packaging configurations: the ATRISORB® GTR Barrier Kit (case kit) and the ATRISORB® GTR Barrier multipack (multipack). The case kit contains the polymer formulation, a barrier forming case with porous pads and spacers, sodium chloride solution, and instructions for use. The multipack contains three dose packs of the polymer formulation, three 18 gauge cannulae, and instructions for use. The barrier functions by isolating the surgical site to facilitate regeneration. It can be preformed using the case or applied directly in situ. The formed barrier is a film that solidifies and bioabsorbs over several months.

for the indications for use stated in the enclosure

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