DESCRIPTION: PEGESORB rapid 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 rapid has excellent handling and knotting properties with minimum tissue response. PEGESORB rapid is the lower molecular weight form of PEGESORB, which enables rapid hydrolysis/absorption of PGA. PEGESORB rapid sutures meet United States Pharmacopoeia (USP) and EuropeanPharmacopoeia (EP) requirements for synthetic absorbable sutures, with the exception of knot tensile strengthin some gauges. Knot tensile strength meets the USP and EP for collagen sutures (Chorda resorbilis sterilis).

INTENDED PURPOSE: PEGESORB rapid is indicated only for use in soft tissue approximation where only short term wound support (7-10 days) is required including ophthalmic surgery. PEGESORB rapid is not indicated for use in cardiovascular and neurological tissues.

PEGESORB rapid surgical sutures are single-use devices.

CLINICALPERFORMANCE CHARACTERISTICS: PEGESORB rapid elicits a minimal tissue reaction and ingrowth of fibrous connective tissue. Progressive loss of tensile strength and eventual absorption of PEGESORB rapid 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 rapid retains approximately of 50% original tensile strength at 5 days. All of the original tensile strength of PEGESORB rapid is essentially lost by 10-14 days post implantation. Mass absorption of PEGESORB rapid takes place after approximately 42 days.

CLINICAL BENEFIT: PEGESORB rapid sutures approximate tissues when used for suturing open wounds hence limiting infection and are also used as a fixation system for soft tissues where a short term support (app. 7 days) is needed. Improves the wound healing properties and ensures an efficient wound closure by maintaining adequate tensile strength and absorption process with minimal, no undue tissue irritation.