Brand name: TEFLENE ®
Material: POLYTETRA FLUORO ETHYLENE (PTFE)
Description:
Polytetra Fluoro Ethylene (PTFE) suture is a non-absorbable, monofilament suture manufactured from 100% high density poly tetra fluoro ethylene (PTFE) polymer, extruded in such a fashion as to produce a structure with a minimal pore size and volume while maintaining integrity and tensile strength. The structure is undyed with no additives.
Available in a broad range of suture sizes and lengths, is either non-needled or attached to standard stainless steel needles of varying types and sizes.
Indications:
Teflene ® is indicated for use in all types of soft tissue approximation and/ or ligation, including dental and general surgeries. The device is not indicated for the use in ophthalmic surgery and peripheral neural tissue.
Application:
The suture should be selected and implanted depending on patient’s condition, surgical experience, surgical technique, and wound size. Normally the skin sutures are removed within 30 days depending on wound condition. The decision of physician is final in removing the skin sutures.
Performance:
Polytetra Fluoro Ethylene (PTFE) suture elicits a minimal initial inflammatory reaction in tissues which is followed by gradual encapsulation of the suture by fibrous connective tissue. PTFE suture is not absorbed or subject to weakening by tissue enzymes and does not degrade in the presence of infection.
Contra indications:
The use of this suture is contraindicated in patients with known sensitivities or allergies to poly tetra fluoro ethylene.
Warnings/ precautions:
- The safety and effectiveness of this suture in ophthalmic, microsurgical and peripheral neural application has not been established.
- Tissue invasion of Polytetra Fluoro Ethylene (PTFE) suture can result in attachment of the suture to the tissue it penetrates in long term use. Such attachment may make removal of the suture difficult.
- Surgeons should consider the in-vivo performance and should be familiar with surgical procedure and techniques involving non-absorbable sutures before employing Polytetra Fluoro Ethylene (PTFE) suture for wound closure, as a risk of wound dehiscence may vary with the site of application and the suture material used.
- In surgery of the urinary or biliary tract, care should be taken to avoid prolonged contact of this or any other suture with salt solution, to prevent calculus formation.
- For single use only. Do not reuse, reprocess or re-sterilize. Reuse, reprocessing or re‐sterilization maycompromise the structural integrity of the deviceand/ or lead to device failure which, in turn, mayresult in patient injury or illness.
- Reuse, reprocessing or re‐sterilization may also create a risk of contamination of the device and/or cause patient infection or cross‐infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another.
- Contamination of the device may lead to injury or illness of the patient.
- Do no use for invasive procedures related to central nervous system and central circulatory system.
Adverse reaction:
Adverse reactions associated with the use of Polytetra Fluoro Ethylene (PTFE) include transitory local irritation at the wound site or transitory inflammatory foreign body response. Like all foreign bodies Polytetra Fluoro Ethylene (PTFE) may potentate an existing infection.
Sterility:
Polytetra Fluoro Ethylene (PTFE) sutures are sterilized by ethylene oxide. Do not re – sterilize! Do not use if package is opened or damaged! Discard opened unused sutures.
Storage:
Recommended storage condition 10°C-35°C, away from moisture and direct heat. Do not use after expiry date.
