Polytetrafluoroethylene
PTFE (TE)
 
Suture Material
DemeTECH PTFE Suture is a monofilament synthetic, non-absorbable, sterile surgical suture composed of high-density polytetrafluoroethylene (PTFE). PTFE Suture is provided undyed (White). PTFE Suture contains no coatings, dyes, or additives. PTFE (polytetrafluoroethylene) suture is MR Safe. DemeTECH PTFE suture meets all requirements established by the United States Pharmacopeia (U.S.P.) for Nonabsorbable Surgical Suture, except for diameter.
 
Intended Use
PTFE (polytetrafluoroethylene) suture is indicated for use in all types of soft tissue approximation and/or ligation, including dental and general surgeries.
 
Actions
PTFE (polytetrafluoroethylene) suture has been shown in clinical trials to elicit a minimal reaction in tissues. PTFE (polytetrafluoroethylene) suture is not absorbed, nor is any significant change in tensile strength retention known to occur in vivo. The DemeTECH PTFE Suture is available in various sizes . The suture is supplied sterile in pre-cut lengths both with and without affixed needles of various straight and curved needle types.
 
Characteristics
 
WARNINGS
Do not resterliize. Discard open, unused sutures and associated surgical needles. Users should be familiar with surgical procedures and techniques involving PTFE (polytetrafluoroethylene) suture before employing PTFE (polytetrafluoroethylene) suture for wound closure, as the risk of wound dehiscence may vary with the site of application and the suture material used. 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. Acceptable surgical practice must be followed with respect to drainage and closure of infected or contaminated wounds.
 
PRECAUTIONS
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. 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 PTFE (polytetrafluoroethytene) suture. Acceptable surgical practice should be followed with respect to drainage and closure of infected or contaminated 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. As with any suture material 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 monofilament sutures.
 
CONTRAINDICATIONS
PTFE (polytetrafluoroethylen)esutureis not indicated for use in ophthalmic surgery, microsurgery and peripheral neural tissue.
 
ADVERSE REACTIONS
Adverse effects associated with the use of this device may include: wound dehiscence, calculi formation in urinary and biliary tracts when prolonged contact with salt solutions such as urine and bile occurs infected wounds, 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 bloodbome pathogens.