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.

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.

CLINICAL PERFORMANCE 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: 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.

DESCRIPTION: 

DESCRIPTION: PEGELAK rapid synthetic, absorbable, surgical surgical sutures made of flexible threads synthesized from 90% glycolite and 10% L-lactite (prepared from glycolic acid and lactic acid) copolymers are used in soft tissue approaches.

The empirical formula of the copolymer is -[(C2H2O2)x(C3H4O2)y] n and x:y=9:1. Its braided structure is covered. The covering material is prepared from calcium siterate and poly(glycolyde-ko-L-lactide). Glacomer 37y] n - x:y=3:7)

When PEGELAC rapid sutures are placed in a living organism, they are absorbed by that organism and do not cause excessive tissue irritation. The mixture with copolymer and calcium site is not antigen and pyrogen, and minimal tissue reaction may occur during absorption.

PEGELAK rapid PEGELAK is a lower molecular weight type of milk, allowing for faster hydrolysis/absorption.

PEGELAK complies with the requirements of the US Pharmacopoeia (USP) and the European Pharmacopoeia (EP) for rapid synthetic absorbable waters, except for the requirements of slightly exceeding the diameters and knotted strength to some extents. Knot strengths comply with USP and EP standards for cathode sutures (Chorda resorbilis sterilis).

INTENDED PURPOSE: PEGELAK rapid is used only in soft tissue zooms and eye (ophthalmic) surgery where short-term (7-10 days) tissue support is required. PEGELAK rapid is not used in cardiovascular and neurological tissues. It is disposable only.

CLINICAL PERFORMANCE CHARASTERISTICS: PEGELAK causes rapid minimal tissue reaction and internal growth of fibrous connective tissues. In PEGELAC rapid sutures, loss of strength and absorption occurs with gradual hydrolysis, and the decomposed glycolic and lactic acid is metabolized within the body.

The absorption process begins with a decrease in tensile strength and continues with mass loss. In animal and in vitro hydrolysis studies, PEGELAK was found to have approximately 50% of the original tensile strength on the 5th day of rapid implantation. All the original strength of PEGELAK rapid is completely lost 10-14 days after implantation. PEGELAK rapid'm is completed after approximately 42 days of complete absorption in mass.

CLINICAL BENEFIT:  PEGELAK rapid, when used for the closure of open wounds, brings the tissue closer, thus limiting infection, and is also used as a fixing system for soft tissues where a short-term support is needed (about 7 days). It improves wound healing properties and provides effective wound closure by maintaining sufficient tensile strength and absorption process without unnecessary tissue irritation.

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.

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.

DESCRIPTION: TEKMON is sterile synthetic, absorbable surgical monofilament suture. The suture is made of Poly(glycolide-co-caprolactone) and the empirical formula is (C2H2O2)m(C6H10O2)n. Poly(glycolide-co- caprolactone) copolymer has been shown to be non-antigenic, non-pyrogenic and elicits only a slight tissue reaction during absorption. TEKMON sutures are dyed by D&C Violet No.2 (C.l. # 60725) during polymerization to enhance visibility in tissue. Sutures are also available in undyed form. TEKMON meets all requirements for synthetic absorbable surgical monofilament sutures specified at the European Pharmacopoeia (EP) and United States Pharmacopoeia (USP).

INTENDED PURPOSE: TEKMON sutures are intended for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular, neurological tissues, microsurgery or ophthalmic surgery.

TEKMON surgical sutures are single-use devices.

CLINICAL PERFORMANCE CHARASTERISTICS: TEKMON 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 TEKMON sutures occurs by means of hydrolysis, where the polymer degrades to the adipic acid which is subsequently absorbed and eliminated by the body. Absorption begins as loss of tensile strength followed by a loss of mass. Absorption test in rats and in vitro hydrolysis show that TEKMON retains approximately 60% of the original strength at 7 days post implantation. At two weeks, approximately 30% of the original strength is retained. Absorption is essentially complete between 90 and 120 days.

CLINICAL BENEFIT: TEKMON sutures provide secure soft tissue approximation and/or ligation in general soft tissue operations where an absorbable material is indicated. TEKMON sutures elicit minimal acute inflammatory reaction in tissue and ingrowth of fibrous connective tissue when used as intended.