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Innovation on a proven basis

A medical milestone: MAGNEZIX®

MAGNEZIX® – a milestone in material research

Metal that can be converted into bone by the body? A utopian idea at first glance, but one which has actually been turned into reality after years of material research: an approved metallic material for bioabsorbable implants - MAGNEZIX®. MAGNEZIX® CS and Pins manufactured from this completely innovative material have comparable mechanical stability to previous metal systems such as screws and Kirschner wires made out of titanium or steel, but are successively resorbed by the body and replaced by bone material. Our implants are therefore the first transformable metal implants in the world.

 

 

 

At the beginning of the 19th century, magnesium was already used experimentally as a resorbable stitch material. The first experiments were also carried out in the field of osteosynthesis and blood vessel surgery using magnesium as a wire. These early studies initially produced very good results. However, the too rapid corrosion of the magnesium frequently led to subsequent complications, which made the material initially appear unattractive for use in implants. It was not until the beginning of the 21st century that magnesium and its alloys were taken into consideration again for applications involving osteosynthesis. This was because, unlike the polymer materials established in medicine, resorbable implant materials made using magnesium have good biocompatibility and usually much higher strengths. And the corrosion properties of the metal previously considered to be uncontrollable, can now be specifically tailored and made controllable by using optimised manufacturing processes (e.g. continuous presses) and by using high-tech alloy systems and coating systems. Numerous investigations have therefore been carried out in recent years on the use of magnesium alloys in biomedical technology applications.
Magnesium research has a long tradition in Hannover. In the interdisciplinary Special Research Unit - biomedical technology - SFB 599) at the Hannover Medical School, work was done for 12 years on new alloys and processes for resorbable Mg implants. The findings gained and published from this work have also had an influence on the development of a magnesium-based implant material developed at the Materials Science and Engineering (MSE) Materials Centre at the Technical University Clausthal. Work began here in 2008 on developing an alloy which later formed the basis for the world's first metallic-bioabsorbable implant material for orthopaedic surgery: MAGNEZIX®
Numerous research alloys made of magnesium are not suitable for use in humans for various reasons. In particular, the corrosion products (gaseous hydrogen) generated during the course of magnesium degradation appeared to be a critical factor. This hydrogen generation (H2) was reduced to a minimum in MAGNEZIX® after numerous test series by optimising the manufacturing process and creating a special formula for the alloy. In addition to basic research using in-vitro tests and animal studies, Syntellix also carried out a clinical prospective-randomised and controlled approval study at the Orthopaedic Clinic of Hannover Medical School at the Annastift (Windhagen et al., 2013) for the purpose of gaining approval in Europe (CE label). This study verified the non-inferiority (same or better suitability) of the MAGNEZIX® screws compared to a conventional titanium implant in Hallux valgus operations. The first implant manufactured using MAGNEZIX® and which gained CE approval in early 2013, is the MAGNEZIX® CS, a fracture-compression screw (Herbert-screw), which won the German Industry Innovation Prize in the very same year. Since gaining the approval, more than 25,000 MAGNEZIX® implants have been sold in more than 20 countries. 



The material MAGNEZIX®

MAGNEZIX® is a magnesium-based alloy, which although having metallic properties, is completely resorbed in the body and is transformed at the same time into bone tissue. The biomechanical properties of MAGNEZIX® are very similar to those of human bone. The alloy is derived from the MgYREZr alloy system pursuant to DIN EN 1753, and has a magnesium concentration of over 90 %, a grain size of less than 10 µm, and is manufactured using a powder-metallurgical process. This enables it to achieve a tensile strength which is very much higher than the resorbable polymers (PLA/PGA), namely in the ideal range between bone and titanium. 

Some studies were also able to show that magnesium alloys have osteoconductive properties. Verification has also been provided that the degradation products of magnesium have anti-bacterial and infection inhibiting properties.

MAGNEZIX® has good compatibility: it contains neither nickel nor aluminium, and there are no allergies with respect to the alloy constituents (high biocompatibility). And there is also no harm done to the body by the absorbed magnesium because it is resorbed over a long period of time and can be ignored when compared to the total amount of magnesium in the body: around 150 mg magnesium per implant (CS 3.2, 20 mm length) roughly corresponds to the amount in three large bottles of standard mineral water, and is well below the levels found in Mg tablets swallowed as a nutritional supplement.

The "ideal" implant disappears on its own

MAGNEZIX® is based on a magnesium alloy and boasts metallic properties (stability, strength, radiological visibility), but can nevertheless be completely resorbed in the body and replaced by the body's own tissue. As regeneration proceeds and the load-bearing strength improves, the healing bone continuously bears increasing loads, and adjusts to the stress it is exposed to, which means that the course of healing can be positively influenced. 

Patients are not happy about metal remaining permanently in their bodies after an operation. Moreover, they are also not keen on having another operation to remove the metal because they are aware of the surgical and infection risks, and wish to remain mobile. As a material for implants, MAGNEZIX® boasts the ideal combination of properties for a temporary but still stable load-bearing component, for which doctors have waited for a long time.

 

 

 

A new dimension in imaging diagnostics

MAGNEZIX® screws and pins are metallic implants. Nevertheless, interference signals in computer tomography as well as MRT diagnostics are reduced to a minimum - the implants generate hardly any artefacts. This considerably improves the ability of surgeons and radiologists to assess the images. Moreover, unlike conventional products made of steel or titanium, MAGNEZIX® implants do not show any significant temperature increase during MRT.

 

 

Osteoconductive and infection inhibiting - MAGNEZIX®

MAGNEZIX® boasts osteoconductive properties. In-vitro findings not only revealed the high vitality of human osteoblasts (bone cells), but also even stimulation in proliferation tests (growth and proliferation). Both the resorption of the implant as well as the formation of new bone (osteoid) on the surface of the resorbed implant were confirmed and verified in histological photographs.  The resorption of the magnesium contained in a MAGNEZIX® implant takes place via corrosion, which leads to the creation of an alkaline environment in the direct vicinity of the implant, in which bacteria have lower survival chances - which is why MAGNEZIX® is expected to have anti-infection properties.

The histological images show the phases of the transformation process of a MAGNEZIX® CS in rabbit animal models. The image shows a cross-section of the hollow compression screw at various post-operative times.