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ADDENDUM TWO P/N 1016262
POLYSORB™ - Coated, Braided Synthetic Absorbable Sutures
Description
POLYSORB™ sutures are composed of LACTOMER™ glycolide/lactide copolymer which is
a
synthetic polyester composed of glycolide and lactide (derived from glycolic and lactic
acids). POLYSORB™ sutures are prepared by coating the suture with a mixture of a
caprolactone/glycolide copolymer and calcium stearoyl lactylate. POLYSORB™ sutures are
colored violet to increase visibility and are also available undyed.
POLYSORB™ sutures meet all requirements established by the United States
Pharmacopeia (USP) and the European Pharmacopeia (EP) except for minor variations in
suture diameter.
Maximum Suture Oversize in Diameter (mm) from U.S.P.
U.S.P. Size U.S.P. Size Designation (mm) Maximum Overage (mm)
3-0 0.20 - 0.249 0.050
Rx Only
For Single Use.
Prior to use see instructions.
Indications
POLYSORB™ Sutures are indicated for use in soft tissue approximation or ligation and
ophthalmic surgery, but not in cardiovascular or neural tissue.
Actions
POLYSORB™ sutures elicit a minimal acute inflammatory reaction in tissue, which is
followed by a gradual encapsulation of the suture by fibrous connective tissue.
Progressive loss of tensile strength and eventual absorption of POLYSORB™ sutures
occurs by means of hydrolysis, where the LACTOMER™ glycolide/lactide copolymer is
broken down to glycolic and lactic acids which are subsequently absorbed and
metabolized by the body. Absorption begins as a loss of tensile strength without
appreciable loss of mass. Studies indicate tensile strength averages for POLYSORB™
sutures are approximately 140% of U.S.P. and E.P. minimum knot strength initially, are
approximately 80% at two weeks and in excess of 30% at three weeks post implant.
Absorption of POLYSORB™ sutures is essentially complete between the 56th and 70th
day.
Contraindiction
POLYSORB™ sutures, being absorbable, should not be used where extended
approximation of tissue is required.
Warnings
Do not resterilize. Sterile unless packaging has been opened or damaged. Discard open,
unused sutures. Store at room temperature. Avoid prolonged exposure to elevated
temperatures.
In surgery of the urinary or biliary tracts, care should be taken to avoid prolonged contact
of this, or any other, suture with salt solutions, as calculus formation may result.
Users should be familiar with surgical procedures and techniques involving absorbable
sutures before employing POLYSORB™ sutures for wound closure, as the risk of wound
dehiscence may vary with the site of application and the suture material used.
Proofed by: Date:
Dimensions checked: Copy checked:
RC041264
McGaw Park, IL
Richard Cisneroz
04-05-12
361-26801
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