DemeSORB ™ (Polyglycolic Acid) Absorable Multifilament Suture

Suture Material

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

INTENDED USE

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

ACTIONS

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.

Characteristics

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

  • A decreased tendency to irritate tissue

  • Greater tensile strength

PRECAUTIONS

  • When handling DemeSORB 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. (i).

  • Under some circumstances, notably orthopedic procedures, immobilization by external support may be employed at the discretion of the surgeon. (ii).

  • Skin sutures that must remain in place longer than 7 days may cause localized irritation and should be snipped off or removed as indicated. (iii).

• In handling this or any other suture material, care should be taken to avoid damage from handling.

  • Avoid crushing or crimping damage due to the application of surgical instruments such as forceps or needle holders. (iv).

  • Adequate knot security requires the accepted surgical technique of flat, square ties, with additional throws as warranted by surgical circumstances and the experience of the surgeon.

DemeSORB 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 delayed absorption. 

ADVERSE REACTIONS

Adverse effects associated with the use of this device include wound dehiscence, failure to provide adequate wound support in the 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.