DemeTech's Polypropylene suture is a nonabsorbable, sterile surgical suture made of synthetic linear polyolefin.

Key Characteristics:

• Color: The suture is blue, enhancing its visibility within the body.
• Tissue Reaction: It induces a minimal acute inflammatory response in tissues. Over time, the suture becomes encapsulated by fibrous tissue.
• Tensile Strength: The suture possesses an extremely high tensile strength, making it durable and reliable.
• Flexibility: It is notably flexible, adapting to the needs of various surgical procedures.
• Tissue Reactivity: Being synthetic and monofilament in nature, DemeTech’s Polypropylene causes only minimal tissue reactivity.
• Ductility: The suture is highly ductile. It can stretch up to 30% before breaking. This characteristic is beneficial post-operation, as it can accommodate tissue swelling without strangulating the tissue.
• Knot Tying: The suture material allows for secure knot tying, ensuring the wound stays closed and heals properly.
• Smoothness: The suture has a very smooth texture, leading to reduced tissue trauma during and after surgery.

In summary, DemeTech's Polypropylene suture offers a combination of strength, flexibility, and reduced tissue reactivity, making it an ideal choice for various surgical applications.

DemeTECH POLYPROPYLENE sutures induce only a slight immediate inflammatory response in tissues. Over time, these sutures become surrounded and encapsulated by fibrous connective tissue. Unlike some other sutures, DemeTECH POLYPROPYLENE sutures are nonabsorbable, meaning they remain in the body indefinitely. Additionally, they maintain their strength once inside the body, with no significant loss in their strength retention while in vivo.

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.

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.

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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.