Johnson & Johnson DePuy Mitek 104106 Manual Del Usuario página 4

ENGLISH
DePuy Mitek Meniscal Fastener
Rx Only
DESCRIPTION
DePuy Mitek Meniscal Fasteners are molded polymeric
implants used to repair tears in the meniscus. Fasteners
provide the means for firmly securing together the edges
of a tear in the meniscus or across the synovial meniscal
junction. The fasteners are available in two materials.
An absorbable fastener of polydioxanone, or a non-
absorbable fastener of polypropylene.
Polydioxanone – Studies have found it to be
nonantigenic, nonpyrogenic, and it elicits only a slight
tissue response during healing.
The absorption characteristics of polydioxanone have
been extensively studied. The general mechanism by
which in vivo degradation of polydioxanone occurs
is hydrolysis. The in vivo hydrolysis of polydioxanone
cleaves the ester linkages and initially results in the loss
of tensile strength. Ultimately the hydrolyzed polymer is
eliminated from the body, primarily in urine.
Data obtained from implantation studies in rodents show
that the PDS polymer is essentially absorbed between
182 and 238 days post implantation
The results of implantation studies of polydioxanone
molded articles in animals indicate that approximately
50% of its original strength remains 5 weeks after
implantation. At 6 weeks post-implantation approximately
20% of its original strength is retained.
Polypropylene – Studies have found it elicits a minimally
acute inflammatory reaction in tissue.
Studies conducted on polypropylene polymer have found
that it does not absorb, nor is it subject to degradation or
weakening by the action of tissue enzymes. The material
is gradually encapsulated by fibrous connective tissue.
A Meniscal Fastener secured in a delivery needle is
supplied sterile. Fasteners are sold in 6 mm and 8 mm
lengths. Contents are sterile unless the package is
damaged or opened. Do not re-sterilize.
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