Frequently asked questions
The use of membranes in bone augmentation
The use of barrier membranes has become the clinical standard for GBR and GTR procedures. To achieve a reliable treatment outcome in bone grafting, the professional societies recommend the use of barrier membranes in combination with bone graft materials. Scientific studies show that bone formation and survival rate of implants increases, when membranes are used. In the U.S., the FDA recommends the use of appropriate membranes during bone regeneration to prevent the migration of bone augmentation particles.
How reliable is the barrier function?
Providing a product with a high therapeutic safety and a reliable and reproducible barrier function was the key objective during Remaix development. We managed to achieve a very high resistance of the membrane towards resorption, without impairment of tissue compatibility. In comparative studies with other non-crosslinked membranes, we have shown that the resorption rate of Remaix is much slower.
What happens during degradation of Remaix?
Remaix will be integrated into the surrounding tissue and will be resorbed as a result of the body‘s natural processes. Resorption of Remaix does not involve the release of toxic degradation products. Neither release of foreign substances (as a result of the use of crosslinking agents), nor pH shifts (as observed during breakdown of synthetic biopolymers) will occur during resorption of Remaix.
Is Remaix chemically crosslinked?
No, during manufacturing of Remaix, no chemical crosslinking is used. In the scientific literature, extensive chemical crosslinking is associated with an increase of the dehiscence rate.
Is there a confusion risk of membrane sides during application?
No, there is no preferred orientation of Remaix during application. Remaix can be applied on both sides.
Is a rehydration or washing step of Remaix required before application?
No, Remaix is highly hydrophilic and is rehydrated within seconds. Additionally, Remaix does not contain potentially toxic remnants of manufacturing or crosslinking processes.
Is Remaix safe?
Yes, comprehensive assessments of Remaix were performed demonstrating its safety. The porcine starting materials are harvested in EU certified facilities in Germany under strict veterinary controls. Validated process steps are implemented to guarantee the viral safety of Remaix. There is no TSE or BSE risk.
Can Remaix be combined with different bone graft materials?
Yes, Remaix can be combined with synthetic and xenogeneic bone graft materials, autologous bone and mixtures thereof.
Remaix is a CE certified Class III medical device. An extensive conformity assessment procedure has been performed according to the European Directive on Medical Devices 93/42/EEC. The Quality Management System of Matricel is certified according to ISO 13485:2010 for the development, production and
distribution of biomaterials for applications in medicine, pharmaceutics and biotechnology. All products are developed and produced in Germany.