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COLLAFLEX Collagen Pericardium Membrane (PDF File)

FAQ

1. What are the indications of COLLAFLEX membranes?
   COLLAFLEX membranes have been cleared for the following bone grafting indications:
   • Simultaneous use of guided bone regeneration (GBR) and implants
   • Augmentation around implants placed in immediate extraction sockets
   • Augmentation around implants placed in delayed extraction sockets
   • Localized ridge augmentation for later implantation
   • Alveolar ridge reconstruction for prosthetic treatment
   • Aid regeneration of bone defects after root resection, cystectomy or removal of retained teeth
   • Guided bone regeneration in dehiscence defects.
2. Should COLLAFLEX membranes be used in a wet or dry state?
   • COLLAFLEX collagen membranes can be used in either wet or dry state. Simply immerse the membrane in sterile saline or the patients blood for about 5 minutes to soften and wet the membrane. Some practitioners prefer to use wet membranes as it is more drapable. However, the rigid nature of the dry membranes may lend itself for certain applications, such as inserting the membrane in a tight lateral sinus window. The dry membrane will soften within minutes upon contact with blood after administration. The hydrated membrane protects the Schneiderian membrane prior to placement of the graft.
3. Can bone tacks be used to stabilize the membranes?
   • COLLAFLEX membranes are strong and pliable and can be stabilized with surgical tacks and sutures.
4. Which side of the membrane should be used against the defect?
   • COLLAFLEX membranes are non-directional; either side of the membrane can face the bone defect. The in vivo study shows no significant differences in bone regeneration.
5. What is the resorption rate of COLLAFLEX membranes?
   • COLLAFLEX collagen membranes substantially resorb within 24 weeks after implantation providing a long barrier function. In vivo, the collagen membranes are biodegraded by endogenous collagenases into carbon dioxide and water.
6. How are COLLAFLEX membranes sterilized?
   • COLLAFLEX membranes are sterilized by gamma radiation.
7. What is the storage condition and shelf life of COLLAFLEX Collagen membranes?
   • The membranes should be stored at ambient conditions (less than 30?) away from direct sunlight. When stored appropriately, the membrane has a shelf life of 3 years.
8. How are COLLAFLEX membranes packaged?
   • The membranes are packed in sealed, sterile double pouches along with a template made of Tyvek material. The template is used to determine the size and shape of the membrane for bone grafting application. The template marked with the word “TEMPLATE is not implantable and must be discarded following application.
9. Can CollaFlex be implanted without primary closure?
   • After administration, COLLAFLEX must be closed with primary closure to prevent infections and complications. In case of dehiscence, the wound may heal without complications by formation of granulation tissue. If infection occurs, practitioner should follow established protocol to monitor the situation and if required, explants the membrane.
10. How are COLLAFLEX membranes made?
    • COLLAFLEX membranes are derived from porcine pericardium through careful purification and sterilization processes to avoid antigenic reactions. These membranes retain the natural porous and fibrous microstructure of the pericardium which promotes rapid angiogenesis and trans-membrane vascularization.
11. What is special about pericardium membranes versus other collagen membranes?
    • The pericardium is a membrane surrounding and protecting the heart of an animal against injury and infection. It consists of an outer layer called fibrous pericardium and an inner layer called serous pericardium. The constant beating of the heart generates a strong, multi-directional collagen fiber structure. As a result, the pericardium is naturally durable and flexible.
12. What are the collagen types of COLLAFLEX membranes?
    • COLLAFLEX membranes consist of mainly Type 1 and Type III collagens. The biocompatible collagen gradually degrades in vivo and integrates into regenerated tissue.
13. Is COLLAFLEX membrane cross-linked?
    • No, COLLAFLEX collagen membranes are made of purified porcine pericardium without cross-linking and do not contain any cross-linking chemicals or agents.
14. What is cross-link and its effects?
    • Cross-link means linking two neighboring polymer molecules by chemical bonding. The cross-linking process involves the use of multifunctional chemical agents to bond adjacent polymers. Excess chemical agents are washed off after reactions. The objective of cross-linking is to lengthen the biodegradation of collagen membranes. However, cross-linking results in a tighter and denser collagen matrix. As a result, cross-linked collagen membranes are stiffer and have less infiltration of blood vessels after implantation.