pegelak 5/0 L239
pegelak 5/0 L239
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pegelak 5/0 L239

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INDICATION: Resorble suture for double layer wound closing, pedicle palatial connective suture, KAZANJIAN vestibuly plastic, Free Gingival Transplants 

DESCRIPTION: PEGELAK sutures are synthetic absorbable sterile surgical sutures which are flexible strands composed of a copolymer prepared and synthesized from 90 percent glycolide and 10 percent L-lactide (derived from glycolic and lactic acids) and are indicated for use in soft tissue approximation. The empirical formula of the copolymer is -[(C2H2O2)x(C3H4O2)y] n - where, x:y=9:1. The braid structure of the suture is coated. Coated suture is prepared by coating suture material with a mixture composed of equal parts of calcium stearate and poly(glycolide-co-L-lactide) Glacomer 37.

PEGELAK sutures when introduced into a living organism are absorbed by that organism and cause no undue tissue irritation. Copolymer and the coating with calcium stearate have been found to be non-antigenic, non-pyrogenic, and elicit only a mild tissue reaction during absorption. The sutures are colored violet (D&C Violet No.2 (C.l. # 60725)) to enhance visibility in tissue. The suture is also available undyed. PEGELAK complies with the requirements of the United States Pharmacopoeia (USP) for Absorbable Surgical Suture and the European Pharmacopoeia (EP) for Sterile Synthetic Absorbable Braided Suture (except for occasional slight oversize in some gauges).

INTENDED PURPOSE: PEGELAK 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.

PEGELAK surgical sutures are single-use devices.

CLINICALPERFORMANCE CHARACTERISTICS: PEGELAK sutures elicit a minimal acute inflammatory reaction in tissue and ingrowth of fibrous connective tissue. Gradual progressive loss of tensile strength and eventual absorption of sutures occur by means of hydrolysis and suture degrades to glycolic and lactic acids which are metabolized in the body.

Absorption begins as a loss of tensile strength followed by a loss of mass. Animal and in-vitro hydrolysis studies indicate that PEGELAK suture retains approximately 75% of the original tensile strength at two weeks post implantation. At three weeks, approximately 40% of the original strength is retained. All of the original tensile strength is lost between four - five weeks post implantation and suture absorption is essentially complete between 56 to 70 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 tensile strength and absorption process with minimal, no undue tissue irritation.