PTFE BARRIER MEMBRANES
Non-absorbable
Sterile regenerative PTFE membranes
description
Regenerative PTFE membranes are sterile, non-absorbable membranes made from polytetrafluoroethylene polymer (PTFE).
PTFE is a biologically inert and tissue compatible material. The regenerative PTFE membranes have been proven to be non-pyrogenic. Regenerative PTFE membranes for Guided Tissue Regeneration (GTR) are used to prevent migration of epithelial cells and connective tissue, which would cause bone growth suppression, and thus provide suitable space for the formation of a natural fibrin structure, the precursor of bone.
Regenerative PTFE membranes are manufactured to European Pharmacopoeia standards.
Indications - Use
PTFE regenerative membranes are a temporary implantable material used in periodontal treatment, implant placement and any dental surgical procedure where a mechanical barrier is required. The membranes provide a mechanism for new soft tissue ingrowth and are used as space-creating barriers in the treatment of periodontal defects.
Carefully open the outer blister tray of the double blister and aseptically remove the inner sterile tray containing the PTFE regenerative membrane. The sterile barrier membrane can then be removed from the sterile inner tray for use during surgery.
Clinical judgment must be made to select patients who will benefit from tissue regeneration, the appropriate configuration for the defect must be selected and implanted, and patients must be managed postoperatively.
If additional stability is desired, the membrane can be stabilized with sutures, surgical staples, and screws.
If the membrane is to be removed, it can easily be grasped with tweezers. A local anesthetic may be given to calm the patient but is generally not necessary.
After removing the membrane, the regenerated tissue will form a new epithelium within 14 to 21 days to complete the original healing process. However, definitive bone maturation will not occur for 6 to 12 months.
Contraindications
Regenerative PTFE membranes, like all other membranes, should not be applied to existing acute infections.
Warnings / Precautions / Interactions
PTFE regenerative membranes should only be used by members of experienced surgical teams. Using the product with improper surgical techniques and biosafety conditions may harm the patient and lead to unsatisfactory results.
In the case of infected wounds, tolerable surgical practices should be followed. If uncontrollable complications, tissue inflammation or signs of infection occur, immediate removal of the material is recommended.
A second surgery to remove the regenerative PTFE membrane is recommended.
sterilization
Regenerative PTFE membranes are sterilized with ethylene oxide gas. They are for single use only and must be discarded if the packaging is damaged or opened. Unused opened membranes must be discarded and must not be sterilized again.
storage
Store below 25οC, do not expose to direct heat or moisture. Do not use after the expiry date.
TITANIUM-PTFE BARRIER MEMBRANES
Non-absorbable
Sterile reinforced regenerative PTFE membranes
description
Ti-PTFE Regenerative Membranes are sterile, non-absorbable membranes made from polytetrafluoroethylene polymer (PTFE) reinforced with medical-grade titanium sandwiched between two layers of PTFE.
PTFE is a biologically inert and tissue compatible material. The regenerative Ti-PTFE membranes have been proven to be non-pyrogenic. Regenerative Ti-PTFE membranes for Guided Bone Regeneration (GBR) aid in new bone formation by acting as biological barriers and preventing the migration of epithelial cells, connective tissue and/or bacteria that could suppress bone growth, thereby providing suitable space for the Formation of a natural fibrin structure, the precursor of bone tissue.
Regenerative Ti-PTFE membranes are manufactured to European Pharmacopoeia standards.
Indications - Use
Regenerative Ti-PTFE membranes are a temporary implantable material used in periodontal treatment, implant placement and any dental surgical procedure where a mechanical barrier is required, and in particular for bone remodeling. The membranes provide a mechanism for new soft and bone tissue ingrowth, and are used as space-creating barriers in the treatment of periodontal defects.
Carefully open the outer blister tray of the double blister and aseptically remove the inner sterile tray containing the Ti-PTFE regenerative membrane. The sterile barrier membrane can then be removed from the sterile inner tray for use during surgery.
Clinical judgment must be made to select patients who will benefit from tissue regeneration, the appropriate configuration for the defect must be selected and implanted, and patients must be managed postoperatively.
If additional stability is desired, the membrane can be stabilized with sutures, surgical staples, and screws.
If the membrane is to be removed, it can easily be grasped with tweezers. A local anesthetic may be given to calm the patient but is generally not necessary.
After removing the membrane, the regenerated tissue will form a new epithelium within 14 to 21 days to complete the original healing process. However, definitive bone maturation will not occur for 6 to 12 months.
Contraindications
Regenerative Ti-PTFE membranes, like all other membranes, are not intended to be applied to existing acute infections.
Warnings / Precautions / Interactions
Regenerative Ti-PTFE membranes should only be used by members of experienced surgical teams. Using the product with improper surgical techniques and biosafety conditions may harm the patient and lead to unsatisfactory results.
In the case of infected wounds, tolerable surgical practices should be followed. If uncontrollable complications, tissue inflammation or signs of infection occur, immediate removal of the material is recommended.
A second operation for the removal of the Ti-PTFE regenerative membrane is recommended.
sterilization
Regenerative Ti-PTFE membranes are sterilized with ethylene oxide gas. They are for single use only and must be discarded if the packaging is damaged or opened. Unused opened membranes must be discarded and must not be sterilized again.
storage
Store below 25οC, do not expose to direct heat or moisture. Do not use after the expiry date.
Symbols used in labeling
