DESCRIPTION: PEGESORB is sterile synthetic, absorbable, braided and coated surgical suture. The suture is made of polyglycolic acid and the empirical formula of the polyglycolic acid is (-O-CH2-CO-O-CH2-CO-)n. The braid structure of the suture is coated. Coated suture is prepared by poly(glycolide(%30)-co-L-lactide(%70)) and calcium stearate mixture. Polyglycolic acid sutures when introduced into a living organism are absorbed by that organism and cause no undue tissue irritation. Polymer and the coating with calcium stearate have been shown to be non-antigenic, non-pyrogenic, and elicit only a mild tissue reaction during absorption. PEGESORB has excellent handling and knotting properties with minimum tissue response. The sutures are coloured violet (D&C Violet No.2 (C.l. # 60725)) to enhance visibility in tissue. The suture is also available undyed. PEGESORB meets all requirements for synthetic absorbable surgical sutures specified at the European Pharmacopoeia (EP) and United States Pharmacopoeia (USP).

INTENDED PURPOSE: PEGESORB is intended for use in general soft tissue approximation and/or ligation including use ophthalmic surgery, but not for use in cardiovascular and neurological tissues.

PEGESORB surgical sutures are single-use devices.

CLINICALPERFORMANCE CHARACTERISTICS: PEGESORB elicits a minimal tissue reaction and ingrowth of fibrous connective tissue. Progressive loss of tensile strength and eventual absorption of PEGESORB sutures occurs by means of hydrolysis gradually and decreases the strength in the body. The absorption process begins a loss of tensile strength followed by a loss of mass. Absorption test in rats and in vitro hydrolysis show that PEGESORB retains approximately 70% of the original tensile strength at two weeks post implantation. At three weeks, approximately 50 % of the original strength is retained for sizes 5/0 and larger and 40 % of its original strength is retained for other sizes. Absorption of PEGESORB suture is essentially complete between 60 and 90 days.

CLINICAL BENEFIT: Providing soft tissue approximation and/or ligation in general soft tissue operations where a medium term absorbable suture is indicated. Improves the wound healing properties and ensures an efficient wound closure by maintaining adequate adequate tensile strength and absorption process with minimal, no undue tissue irritation.