TEFLENE - Polytetrafluoroethylene (PTFE) Sutures

TEFLENE is a PTFE suture brand manufactured by Dolphin Sutures from India. We are the first and only Indian brand to introduce PTFE sutures in India. Our products also CE certified with DNV GL Presafe, Norway.

PTFE suture is a monofilament non-absorbable, extremely soft and smooth material composed of a strand of polytetrafluoroethylene (PTFE). This material is a synthetic fluoropolymer of tetrafluoroethylene that is very strong, knots well and biologically inert.

Our suture is white in color and some of the SKUs are available with black needles for enhancing the visibility during the surgery. Teflene material has a very low friction coefficient, meaning it slides easily through tissue compared to other materials, thereby limiting the possibility of tissue damage. This feature, along with the monofilament construction, prevents the possibility of bacterial wicking into the surgical site.

Our PTFE suture is designed to be an ultra-soft, high density surgical suture making it an ideal choice for oral and maxillofacial surgery.

MaterialPolytetrafluoroethylene
CoatingUncoated
ColourUndyed
AbsorptionNot applicable
Sizes6-0, 5-0, 4-0, 3-0, 2-0
Tissue ReactionGrade -2, Reactivity - Mild
ApplicationsDental, skin closure, general surgery

ptfe IFU Dolphin Sutures

  • Features

    • 100% Medical Grade PTFE which is biologically inert and highly bio-compatible.
    • Monofilament structure does not allow bacteria wicking into the surgical site.
    • Teflene sutures being non-absorbable keeps the surgical site reliably closed.
    • Soft and flexible for patients (not stiff like most monofilaments).
    • Teflene sutures are available from U.S.P. size 2-0 to size 6-0.
  • Advantages

    • No package memory and Ultra-smooth surface.
    • Excellent security with snug and flattened knot.
    • High tensile strength.
    • Proprietary construction reduces the potential for bacterial migration into the surgical site.
    • Provides support to the tissues during the whole healing process unlike other absorbable sutures.
    • Biologically inert and chemically non-reactive and decreased redness, and decreased inflammation around suture lines.
  • Models

    CODE NO.NEEDLE PROFILENEEDLE LENGTHSUTURE LENGTHSUTURE SIZE
    PTTS 12003/8 circle reverse cutting19mm50cm2-0
    PTTS 12023/8 circle reverse cutting25mm50cm2-0
    PTTS 1303VB3/8 circle reverse cutting - Black Needle16mm50cm3-0
    PTTS 13003/8 circle reverse cutting19mm50cm3-0
    PTTS 13023/8 circle reverse cutting25mm50cm3-0
    PTTS 1400VB3/8 circle reverse cutting - Black Needle12mm50cm4-0
    PTTS 1402VB3/8 circle reverse cutting - Black Needle16mm50cm4-0
    PTTS 14043/8 circle reverse cutting19mm50cm4-0
    PTTS 1500VB3/8 circle reverse cutting - Black Needle12mm50cm5-0
    PTTS 1502VB3/8 circle reverse cutting - Black Needle16mm50cm5-0
    PTTTS 16003/8 circle reverse cutting12mm50cm6-0
  • Packing

    • PTFE sutures are individually packed in a primary medical grade paper folder.
    • Individually packed sutures are then packed in a peel-open aluminum foil
    • Sutures are further packed in small cartons made from premium 320 GSM Cyber XLPac in 12 suture pack.
    • Boxes are further laminated in tamper proof film to protect it from dirt/dust.
    • Further, the sutures are packed in an export worthy 7 ply master carton which can accommodate 100 boxes ( 70 x 30 x 30 cms) – weighing up to 9 to 10kg and 200 boxes ( 70 x 29 x 59 cms) – weighing up to 18kg
  • Usage

    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.

    suture usage Dolphin Sutures

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