Polydioxanone Barbed suture is indicated for use in soft tissue approximation where use of absorbable sutures is appropriate.

Two important characteristics describe the in vivo performance of absorbable sutures: first, tensile strength retention, and second, the absorption rate (loss of mass). POLYDIOXANONE Barbed synthetic absorbable suture has been formulated to minimize the variability of these characteristics and to provide wound support through an extended healing period. Data obtained from implantation studies in rats show that the absorption of these sutures is minimal until about the 90th post-implantation day. Absorption is essentially complete within seven to eight months.

Users should be familiar with surgical procedure and techniques involving absorbable sutures before employing Polydioxanone Barbed sutures for wound closure, as risk of wound dehiscence may vary with the site of application and the suture material used. Physicians should consider the in vivo performance (under ACTIONS section) when selecting a suture for use in patients. 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. The safety and effectiveness has not been established for use in fascial closures (including abdominal wall, thoracic and extremity fascial closures), gastrointestinal anastomoses, cardiovascular tissue, neural tissue, ophthalmic surgery or for use in microsurgery, and the closure of other soft tissues that will be under excess tension. Under certain circumstances, notably orthopedic procedures, immobilization by external support may be employed at the discretion of the surgeon. As with any foreign body, prolonged contact of any suture with salt solutions, such as those found in the urinary or biliary tracts may result in calculus formation. As an absorbable suture, this suture may act transiently as a foreign body. Acceptable surgical practice should be followed for the management of contaminated or infected wounds. As this is an absorbable suture material, the use of supplemental nonabsorbable sutures should be considered by the surgeon in the closure of the sites which may undergo expansion, stretching or distention or which may require additional support.

• Polydioxanone Barbed suture contains unidirectional barbs to anchor tissues and does not require knots to approximate opposing edges of a wound. Tying knots on the barbed section of the material will damage the barbs and potentially reduce the suture tensile strength and barb effectiveness. Additionally, when completing placement, an additional backstitch or bite of tissue lateral to the end of the incision is required to lock the device in place. • Avoid contacting the suture and associated needles with other materials (e.g. surgical gauze, drapes, etc.) in the surgical field to prevent ensnaring on the barbs. If the barbs catch, carefully pull the material in the opposite direction of the needle to disengage it from the barbs. • Care should be taken to avoid damage when handling. Avoid crushing or crimping the suture material with surgical instruments, such as needle holders and forceps. Do not pull the suture out of the package by the needles as this can cause the barbs to catch on one another. Do not attempt to remove memory in the polymer by running fingers down the suture material as this can damage the barbs. • Infections, erythema, foreign body reactions, transient inflammatory reactions and in rare instances wound dehiscence are typical or foreseeable risks associated with any suture and hence are also potential complications associated with Polydioxanone Barbed suture. • When using barbed suture subcutaneously, the device should be placed as deeply as possible in order to minimize erythema and induration normally associated with absorption. • Acceptable surgical practice should be followed with respect to drainage and closure of infected wounds. • To avoid damaging needle points and swage areas, grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the swaged end to the point. • Reshaping needles may cause them to lose strength and be less resistant to bending and breaking. • Users should exercise caution when handling surgical needles to avoid inadvertent needle sticks. Discard used needles in “sharps” containers.

These sutures, being absorbable, are not to be used where prolonged (beyond six weeks) approximation of tissues under stress is required and are not to be used in conjunction with prosthetic devices, i.e., heart valves or synthetic grafts

Adverse effects associated with the use of this device may include, wound dehiscence, failure to provide adequate wound support in closure of the site where expansion, stretching or distension occur, failure to provide adequate wound support in elderly, malnourished or debilitated patients or in patients suffering from condition which may delay wound healing, infection, minimal acute inflammatory tissue reaction, localized irritation when skin sutures are left in place for greater than 7 days, suture extrusion and delayed absorption in tissue with poor blood supply, calculi formation in urinary and biliary tracts when prolonged contact with salt solutions such as urine and bile occurs and transitory local infection as the wound site. Broken needles may result in extended or additional surgeries or residual foreign bodies. Inadvertent needle sticks with contaminated surgical needles may result in the transmission of bloodborne pathogens. Due to prolonged suture absorption, some irritation and bleeding may occur.

The DemeTECH Polydioxanone Barbed suture is a monofilament barbed synthetic absorbable suture is available in sizes 5-0 through 1 (metric sized 1.5-5). The suture is supplied sterile, dyed with D&C Violet 2 in pre-cut lengths both without and with affixed needles of various straight and curved needle types, supplied in cartons of one dozen.

It is recommended that the Sutures are stored below 25°C. Keep away from direct heat and moisture. Carefully observe the expiration date.