CYTO PLAST PTFE Titanium Reinforced Membranes Instruction Manual
- September 3, 2024
- CYTO PLAST
Table of Contents
CYTO PLAST PTFE Titanium Reinforced Membranes
Product Specifications
- Product Name: CytoplastTM Titanium-Reinforced PTFE Barrier Membranes
- Material: Titanium-Reinforced Non-Resorbable PTFE
- Implantable: Temporarily for use as a space-making barrier in the treatment of periodontal defects
- Design: Not suitable for load-bearing conditions
Product Usage Instructions
Indications
CytoplastTM Titanium-Reinforced PTFE Membranes are intended for use as a
space-making barrier in the treatment of periodontal defects. They are
temporarily implantable.
Contraindications
Avoid using CytoplastTM Titanium-Reinforced PTFE Membranes under load-bearing
conditions.
Warnings
Barrier membranes should only be used with stable endosseous implants. Long-
term safety and effectiveness should be considered.
Labeling Symbols
Symbols may be used on package labeling for easy identification. Always
consult the instructions for use.
Frequently Asked Questions (FAQ)
What are the main uses of CytoplastTM Titanium-Reinforced PTFE Barrier
Membranes?
The main use of these membranes is as a space-making barrier in the treatment
of periodontal defects.
Regenerative Barrier Membranes
INSTRUCTIONS FOR USE
INTRODUCTION
The user of Osteogenics Biomedical products has the duty to determine whether
or not any product is suitable for the particular patient and circumstances.
Osteogenics Biomedical disclaims any liability, express or implied, and shall
have no responsibility for any direct, indirect, punitive or other damages,
arising out of or in connection with any errors in professional judgment or
practice in the use or installation of Osteogenics products. IMPORTANT: Read
this entire package insert prior to use and follow all instructions carefully.
Improper handling, preparation, surgical technique or postoperative care may
adversely affect the safety and/or performance of the membrane.
DESCRIPTION
Cytoplast™ Titanium-Reinforced PTFE Membranes are composed of proprietary 100%
polytetrafluoroethylene
sheet, reinforced with a titanium frame embedded between two layers of PTFE.
PTFE is a biologically inert and tissue compatible material. Cytoplast™
Titanium-Reinforced PTFE Membranes are a high-density sheet with a surface
structure and porosity suitable to prevent integration and passage of bacteria
within the interstices of the material, and simultaneously facilitate adhesion
of host cells to the material. Cytoplast™ Titanium-Reinforced PTFE Membranes
are designed to reduce the migration and establishment of gingival soft tissue
derived cells into bony defects thus providing a more favorable environment
for neovascularization and bone derived cells to repopulate and repair the
defect. Since space-making is critical to this procedure, the membrane is
sufficiently stiff to prevent spontaneous collapse but supple enough to
conform easily to tissue contours and reduce perforations of overlying soft
tissue.
INDICATIONS
Cytoplast™ Titanium-Reinforced PTFE Membranes are a temporarily implantable
material (non-resorbable) for use as a space-making barrier in the treatment
of periodontal defects.
CONTRAINDICATIONS Cytoplast™ Titanium-Reinforced PTFE Membranes are not
designed for use under load bearing conditions.
WARNINGS
Barrier membranes should be used only with stable endosseous implants, and the
long term safety and effectiveness of maintaining endosseous implants in
regenerated osseous tissue on alveolar ridges has not been determined.
CAUTIONS
- U.S.A. Federal Law restricts the sale, distribution or use of this device to, by or on the order of a licensed practitioner.
- Do not use if package has been opened or damaged prior to use.
- Do not reuse or re-sterilize Cytoplast™ Titanium-Reinforced PTFE Membranes. Safety and effectiveness following reuse or re-sterilization of the Cytoplast™ Titanium-Reinforced PTFE Membranes has not been established.
- Cytoplast™ Titanium-Reinforced PTFE Membranes should not be used in the presence of active infection.
ADVERSE REACTIONS
None reported.
MRI SAFETY INFORMATION
Non-clinical testing has demonstrated that Cytoplast™ Titanium-Reinforced PTFE
Membranes are MR Conditional. A patient with this device can be safely scanned
in an MR system meeting the following conditions:
- Static magnetic field of 1.5 T and 3.0 T
- Maximum spatial gradient of 3,000 gauss/cm (30 T/m)
- Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 2 W/kg (Normal Operating Mode)
- Under the scan conditions defined above, the Cytoplast™ Titanium-Reinforced PTFE Membranes are expected to produce a maximum temperature rise of less than 2.3°C after 15 minutes of continuous scanning.
In non-clinical testing, the image artifact caused by the device extends approximately 3 mm from the implant when imaged with a gradient echo pulse sequence and a 3.0 T MR system.
MEMBRANE INSERTION
- Carefully open the outer tray of the double blister and aseptically remove the sterile inner tray containing the Cytoplast™ Titanium-Reinforced PTFE Membrane in the sterile field. The sterile barrier membrane can then be removed from the sterile inner tray for usage during the surgical procedure. Handle the membrane only with sterile surgical gloves, which have been washed in sterile water to remove the talc, or with sterile atraumatic forceps. The membrane may be cut to the desired configuration. Titanium is easily cut with sharp scissors. After trimming, there should be no sharp corners or rough edges. Note: For best results with textured material, place dimples side up towards gingival tissue. To enhance space-making capability, the material may be curved over the fingertips or a sterile instrument handle to create a dome shape, if desired.
- The membrane should be trimmed to extend 3-4mm beyond the defect margins to provide adequate protection of the bone defect and enhance membrane stability. The membrane should be trimmed to remain at least 1 mm from adjacent, uninvolved teeth. Care should be exercised during placement of the membrane to prevent delamination. Trimming of the membrane close to the titanium frame or excessive bending of the frame can increase the risk of delamination. Sections of the membrane that become delaminated during placement should not be used. In rare instances, the titanium frame may perforate through the PTFE material during handling. If this occurs, the membrane should not be used.
- If additional stability is desired, the membrane may be stabilized with sutures, surgical tacks or screws. The use of a non-resorbable monofilament suture is recommended by the manufacturer. Loss of tensile strength during the initial 2-week healing period can lead to premature membrane exposure.
- Adequate flap release must be accomplished in order to achieve a tension-free closure if primary closure is desired. Vertical incisions, if used, must be remote from the location of the membrane. A double layer closure, with a deep layer of horizontal mattress sutures followed by a standard wound closure with interrupted sutures, is recommended.
MEMBRANE EXPOSURE
Depending on the size and complexity of a given defect, maintenance of primary
closure may be required for predictable bone regeneration. If primary closure
is desired, and premature exposure of the membrane occurs,
the manufacturer recommends following recognized published protocols for
management and prevention of PTFE membrane exposures.
MEMBRANE REMOVAL
The membrane is not intended to remain in place as a permanent implant and
should therefore be removed following the bone regeneration procedure. When
removal is desired, the membrane may be easily removed, if exposed, by
grasping with forceps and gently removing it from the tissue. Anesthesia may
be provided to enhance patient comfort, but is usually not necessary. If
primary closure is obtained at placement, surgical exposure will be required
for removal.
Following membrane removal, the regenerated tissue will re-epithelialize
within 14 to 21 days to complete the
initial healing process. However, final bone maturation will not occur for 6
to 12 months. This time frame should be considered in treatment planning cases
involving heavy prosthetic loading of regenerated bone.
AVAILABILITY
Cytoplast™ Titanium-Reinforced PTFE Membranes are provided sterile in a
variety of shapes and sizes, and are titanium reinforced.
LABELING SYMBOLS
Symbols may be used on package labeling for easy identification.
Manufacturer
Use By
Do Not Reuse
Caution
Do Not Use if Package is Damaged
Sterilized Using Ethylene Oxide
Temperature Limit 15 – 30°C (59 – 86°F)
Do Not Resterilize
Lot Lot Number
REF Catalog Number
Authorized Representative in the European Community
MR Conditional
Consult instructions for use
Osteogenics Biomedical, Inc. 4620 71st Street, Bldg 78-79 Lubbock, TX 79424 USA www.osteogenics.com
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