DemeLENE™(POLYPROPYLENE) Monofilament (Non-absorbable)

Description:

Suture Material

DemeTECH Polypropylene sutures are inert, nonabsorbable, sterile surgical sutures composed of an isotactic crystalline stereoisomer of polypropylene, a synthetic linear polyolefin. The suture pigment used CU – Phtalocyanine Blue Dye to enhance visibility. All DemeTECH sutures meet the requirements established by U.S.P.

INTENDED USE

The DemeTECH Nonabsorbable Polypropylene Suture with and without needles is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures. Product is intended for long term use over 30 days.

ACTIONS

DemeTECH POLYPROPYLENE sutures elicit a minimal acute inflammatory reaction in tissue, which is followed by gradual encapsulation of the suture by fibrous connective tissue. DemeTECH POLYPROPYLENE sutures are not absorbed, nor is any significant change in strength retention known to occur in vivo.

Characteristics

DemeTech’s Polypropylene suture is a nonabsorbable, sterile surgical suture composed of a synthetic linear polyolefin. DemeTech’s Polypropylene is blue to enhance visibility in the body. DemeTech’s Polypropylene suture elicits a minimal acute inflammatory reaction in the tissue, followed by gradual encapsulation of the suture by fibrous tissue. - Extremely high tensile strength - Very flexible - Due to its synthetic and monofilament characteristic, DemeTech’s Polypropylene elicits only minimal tissue reactivity. - DemeTech’s Polypropylene is highly ductile. It extends 30% prior to rupture of the thread, allowing for the post-operative swelling of tissue and avoiding possible strangulation of tissue. - Allows for secured knot tying. - Extremely smooth textile, resulting in minimal tissue trauma.

WARNINGS:

• Do not resterilize. Discard open, unused sutures. • Users should be familiar with surgical procedures and techniques involving nonabsorbable sutures before employing DemeTECH Polypropylene sutures for wound closure, as risk of wound dehiscence may vary with the site of application and the suture material used. • As any foreign material in the presence of bacterial contamination may enhance bacterial infectivity, acceptable surgical practice must be followed with respect to drainage and closure or infected or contaminated wounds. • 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.

PRECAUTIONS

In handling this 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 of single suture strands. The use of additional throws is particularly appropriate when knotting polypropylene sutures. 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.

ADVERSE REACTIONS

Adverse effects associated with the use of this device include wound dehiscence, calculi formation in urinary and biliary tracts when prolonged contact with salt solutions such as urine and bile occurs, infection, minimal acute inflammatory tissue reaction, and, pain, edema, and erythema at 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.

DELIVERY FORM:

The DemeTECH POLYPROPYLENE sutures, pigmented, are available in various sizes. All DemeTECH POLYPROPYLENE sutures are available in a variety of lengths, with permanently attached needles. Needles may be manufactured using non-magnetic stainless steel alloys.

More information: https://www.demetech.us/product/sutures/Polypropylene