DemeSORB Polyglycolic Acid PGA Sutures Reverse Cutting Needle Box/12

DemeTECH’s Polyglycolic Acid (PGA) suture is a coated, braided synthetic absorbable suture, composed of the homopolymer of glycolic acid and coated with polycaprolactone and calcium stearate. The PGA Suture is available in violet and colorless from sizes: USP 8/0 to USP 2

PGA Suture is indicated for use in general soft tissue approximation and / or ligation, including use in ophthalmic surgery.

A slight tissue inflammation may occur when PGA Sutures are placed in tissue, which is characteristic of foreign body response, which is followed by gradual encapsulation by connective tissue.

Sutures by DemeTech - Polyglycolic Acid suture is a synthetic, absorbable, sterile, surgical suture composed of 100% glycolide. DemeTech’s Polyglycolic Acid Sutures are available in either violet or colorless. The chemical formula of DemeTech’s PGA is (C2H2O2)n. Clinical trials have shown that after two weeks, approximately 84% of DemeTech’s PGA initial strength remained. At four weeks, approximately 23% of DemeTech’s PGA linear tensile strength remained. Sutures by DemeTech - Polyglycolic Acid Suture has been found to be nonantigenic and elicit only mild tissue reactivity during the absorption process. - Polyglycolic Acid, better known as PGA, is composed of polymers of glycolide acids. - DemeTech’s PGA is coated to allow for easier passage through tissues with only minimal drag. Coated PGA sutures facilitate: - Easy tissue passage - Precise knot placement - Smooth tie down - Greater tensile strength - A decreased tendency to irritate tissue

• Do not resterilize. Discard open unused sutures. Store at room temperature. Avoid prolonged exposure to elevated temperatures. • As with any foreign body, prolonged contact of this or any other suture with salt solutions, such as those found in the urinary or biliary tracts, may result in calculus formation. • Users should be familiar with surgical procedures and techniques involving absorbable sutures before employing PGA synthetic absorbable suture for wound closure, as risk of wound dehiscence may vary with the site of application and the suture material used. • Acceptable surgical practice should be followed with respect to drainage and closure of contaminated or infected wounds. • The use of this suture may be inappropriate in elderly, malnourished, or debilitated patients, or in patients suffering from conditions which may delay wound healing. • As this is an absorbable suture material, the use of supplemental non-absorbable sutures should be considered by the surgeon in the closure of sites which may undergo expansion, stretching, or distention, or which may require additional support. • Do not reuse. The reuse of single-use devices can cause cross contamination and affect the device safety, performance and effectiveness, exposing patients and staff to unnecessary risk. The design and material used are not compatible with conventional cleaning and sterilization procedures.

When handling PGA Sutures, it is necessary to handle the suture and needle with care, paying particular attention to the needle and avoiding damage being caused by the needle holders. The user should have sufficient knowledge and be familiar with absorbable Surgical Sutures and the particular decreasing tensile strength, before handling Sutures. Under some circumstances, notably orthopedic procedures, immobilization by external support may be employed at the discretion of the surgeon. Skin sutures which must remain in place longer than 7 days may cause localized irritation and should be snipped off or removed as indicated. In handling this or any other suture material, care should be taken to avoid damage from handling. Avoid crushing or crimping damage due to application of surgical instruments such as forceps or needle holders. Adequate knot security requires the accepted surgical technique of flat, square ties, with additional throws as warranted by surgical circumstance and the experience of the surgeon. The use of additional throws may be particularly appropriate when knotting monofilaments. PGA is not suitable for elderly or debilitated patients or patients with retarded wound healing. Tissue with poor blood circulation may reject the suture material due to the delayed absorption.

Adverse effects associated with the use of this device include wound dehiscence, failure to provide adequate wound support in closure of the sites where expansion, stretching or distension occur, failure to provide adequate wound support in elderly, malnourished or debilitated patients or in patients suffering from conditions -which may delay wound healing, wound infection, minimal acute inflammatory tissue reaction, localized irritation when skin suture are left in place for greater than 7 days, calculi formation in urinary and biliary tracts when prolonged contact with salt solutions such as urine and bile occurs, and transitory local irritation.

After which absorption by hydrolysis begins, where the polymer degrades to glycolic acid, which is absorbed by the body. PGA elicits a minimal acute inflammatory reaction in tissues, which is followed by gradual encapsulation of the suture by fibrous connective tissue. Progressive loss of tensile strength and eventual absorption of PGA synthetic absorbable sutures occurs by means of hydrolysis, where the polymer degrades to either glycolic acid or glycolic and lactic acids which are subsequently absorbed and metabolized by the body. Absorption begins as a loss of tensile strength without appreciable loss of mass. Implantation studies indicate that PGA retains approximately 84 % of its original tensile strength at two weeks post implantation, with approximately 51% remaining at three weeks. Absorption of PGA absorbable synthetic suture is essentially complete between 60 and 90 days.