DESCRIPTION: POLITER® is a braided, non-absorbable, silicone coated, sterile surgical suture made of polyester (Polyethylene terephthalate). The suture is prepared by braiding very fine filaments and then by coating with silicone mixture. POLITER® is dyed green (D & C Green No 6) for higher visibility. Some combinations are also available as undyed. Pledgets, as accessories to sutures, are non-absorbable, undyed fabric precut pieces made of polytetrafluoroethylene (PTFE). POLITER® meets all requirements for non-absorbable surgical sutures specified by the European Pharmacopoeia (EP) and United States Pharmacopoeia (USP).

INTENDED PURPOSE: POLITER® is intended for use in general soft tissue approximation and/or ligation including use in cardiovascular, orthopedic, general, neurological and ophthalmic surgery procedures. Pledget use is limited to cardiovascular surgery as a pad between the suture area and the tissue surface to increase the load bearing area.

POLITER® surgical sutures and pledgets are single-use devices.

CLINICAL PERFORMANCE CHARASTERISTICS: POLITER® elicits a minimal acute inflammatory reaction in tissue, followed by a gradual encapsulation of the suture by fibrous connective tissue. Implantation studies in animals show no significant decline in polyester suture strength over time. Both polyester fiber suture material and coating are pharmacologically inert.

CLINICAL BENEFIT: POLITER® sutures approximate soft tissues when used for suturing wounds hence limiting infection and/or used for ligation in general soft tissue operations including cardiovascular and neurological procedures.

POLITER® aims to evoke minimal inflammatory response in tissue while improving the wound healing properties and ensures an effective wound closure by maintaining tensile strength indefinitely.