DESCRIPTION: PEDESENTE is sterile synthetic, absorbable surgical monofilament suture. The suture is made of polydioxanone and the empirical formula is (-O-CH2-CH2-O-CH2-CO-)n. Polydioxanone polymer has been shown to be nonantigenic, non-pyrogenic and elicits only o slight tissue reaction during absorption. PEDESENTE sutures are dyed with D&C Violet No.2 (C.l. # 60725) during polymerization to enhance visibility in tissue. The suture is also available undyed (beige).

PEDESENTE meets all requirements for synthetic absorbable surgical monofilament sutures specified at the European Pharmacopoeia (EP) and United States Pharmacopoeia (USP).

 

INTENDED PURPOSE: PEDESENTE is intended for use in general soft tissue approximation and/or ligation including use in pediatric cardiovascular tissue where growth is expected and in ophthalmic surgery, where the use of an absorbable suture and extended wound support (up to six weeks) is desirable. PEDESENTE surgical sutures are single-use devices.

 

CLINICAL PERFORMANCE CHARASTERISTICS: PEDESENTE elicits a minimal initial inflammatory reaction in tissues and is eventually replaced with an in-growth of fibrous connective tissue. Progressive loss of tensile strength and eventual absorption of PEDESENTE sutures occurs by means of hydrolysis, where the polymer degrades to monomers which are subsequently absorbed and eliminated by the body. Absorption begins as loss of tensile strength followed by a loss of mass. Studies show that approximately 75 % of the original strength is retained at two weeks after implantation. At four weeks post implantation, approximately 60 % of the original strength is retained. Absorption test in rats and in vitro hydrolysis of PEDESENTE show that absorption is minimal until about the 90th post implantation day and is essentially complete between 180 and 210 days.

CLINICAL BENEFIT: PEDESENTE ensures a secure soft tissue approximation and/or ligation until it is absorbed. The indications also include pediatric cardiovascular tissues where growth is expected and ophthalmic surgery. The wound support is approximately 75 % at 2 weeks, 60 % at 4 weeks and the suture is totaly absorbed in 180-210 days.