Monoswift® is a synthetic absorbable monofilament surgical suture, composed of Poly(Glycolide-Co-Caprolactone) (PGCL). PGCL
synthetic absorbable monofilament sutures are available dyed with FD&C violet 2 or undyed (natural). PGCL synthetic absorbable
monofilament suture meets all requirements established by the United States Pharmacopoeia, except for diameter. Monoswift®
synthetic absorbable monofilament sutures are indicated for use in soft tissue approximation and/or ligation, but not for use in
cardiovascular or neurological surgery, micro-surgery, or ophthalmic surgery. These sutures, being absorbable, are not to be used
where extended approximation of tissue is required. The use of this suture may be inappropriate in elderly, malnourished, and
debilitated patients, or any patients suffering from conditions that may delay wound healing. Implantation studies in animals
indicate that PGCL suture retains approximately 70% of its original tensile strength at 7 days post implantation, approximately 40%
of its original tensile strength at 14 days, and approximately 12% at 21 days post implantation. Absorption begins as a loss of
tensile strength without appreciable loss of mass, absorption of Monoswift® is essentially complete between 91 and 120 days. For
soft tissue approximation and/or ligation.