The pilot project - highly innovative and revolutionary
After many years of research work, Syntellix AG was successful in producing bioabsorbable compression screws which satisfy the demands of doctors and patients. Accompanying bilateral research projects and studies verified that the material and the manufacturing quality of the metallic MAGNEZIX® implants fully conform in all aspects with the very high demands for stability and biocompatibility.
And our research activities continue:
In-vivo animal experiments and clinical studies in particular carried out in cooperation with partners from the MHH Annastift clinic provide the basic knowledge and preconditions for any approval for new implants and areas of application:
- This included the clinical study for the approval of the MAGNEZIX® compression screw, which was successfully carried out in the MHH Orthopaedics Department at the Annastift.
- In addition, in-vivo studies on rabbits played a crucial part in verifying the biocompatibility of our MAGNEZIX® material pursuant to ISO 10993.
- In the meantime, scientific studies on the medium term results (2 years) and the long-term results (3 years) have already been published to verify the successful use of MAGNEZIX® under everyday clinical conditions.
- Ongoing research activity is looking at new areas of application and new material technologies. Future product innovations in the form of special implants for various fixations in a range of areas of application are currently in the development and testing stage.
Partnership with the
Helmholtz Virtual Institute
Syntellix AG supports the MedBioMat virtual institute of the Helmholtz Association as an associated partner. The close cooperation with the Helmholtz centre in Geesthacht also involves the University Clinic Hamburg-Eppendorf, the Hannover Medical School, and the Laura Bassi Centre of excellence of the University of Graz in Austria. The virtual institute "In-vivo studies of biodegradable magnesium-based implant materials" - MedBioMat - will develop aluminium-free, bioresorbable magnesium alloys which can be used as orthopaedic implants in children amongst others.
More information available here.
Additional initiatives in Germany and at a European level are currently in the application phase. The multi-centre PMCF study will start shortly on the use of MAGNEZIX® implants for scaphoid fractures. We will provide you with further information in the News section as soon as this and other projects begin.
Innovation continues: new MAGNEZIX® sizes and pins
MAGNEZIX® opens up numerous areas of application. In addition to the well-known MAGNEZIX® CS 3.2 material, this has been further expanded again with the variations: MAGNEZIX® CS 2.0, and CS 2.7 in 2015. We are continually further developing MAGNEZIX® for other indications and new areas of application. The MAGNEZIX® Pin was launched on the market in 2016 especially for trauma and sports applications.
Our objective: developing new formats and innovative materials for transformable implants.