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Innovation on a proven basis

A medical milestone: MAGNEZIX®

MEDICAL INNOVATION: A METAL SCREW THAT TURNS INTO BONE

Conventional metal implants made of steel or titanium are often removed in a second surgery because they can cause discomfort and undesired reactions or are perceived as disturbing by the patient. Implant removal is a considerable concern after orthopedic surgery and a burden for surgeons and patients. However, MAGNEZIX® implants save patients the pain and risks of a second surgery for implant removal.

MAGNEZIX® implants are the modern alternative to conventional metal and polymer-based implants and set new standards for orthopedics, traumatology and sports surgery. MAGNEZIX® is a trademark for implants manufactured from the world‘s first bioabsorbable material consisting of a magnesium alloy for medical applications in orthopedic and trauma surgery. MAGNEZIX® implants are metallic and several times more stable than conventional resorbable implants made of PGA or PLA. The favorable bone-similar mechanical properties (high stability and high elasticity) of MAGNEZIX® implants prevent/reduce “stress-shielding” (bone atrophy due to shielding from load). Unlike conventional metal screws or wires made of titanium or steel, MAGNEZIX® implants do not need to be removed in a second surgery because they degrade in the body and are replaced by the body’s own tissue. As a result, they set completely new standards in surgery.



The material MAGNEZIX®

MAGNEZIX® is a magnesium-based alloy that has metallic properties, but is completely absorbed in the body and simultaneously transformed into bone tissue. The biomechanical properties of MAGNEZIX® are very similar to those of human bone. The alloy has a magnesium concentration of over 90%, a grain size of less than 10 µm and is produced in a unique and highly sophisticated powder metallurgical process. This results in a tensile strength that is significantly higher than that of resorbable polymers (PLA/PGA), namely in the ideal area between bone and titanium.  

Some studies have shown that magnesium alloys have osteoconductive properties. It has also been shown that magnesium degradation products have antibacterial and anti-infective properties.

MAGNEZIX® has good compatibility: it contains neither nickel nor aluminium, and there are no allergies known to the components of the alloy (high biocompatibility). The magnesium absorbed does not harm the body either, as it is absorbed over a longer period of time and can be ignored compared to the total amount of magnesium in the body: Approximately 150 mg magnesium per implant (CS 3.2, 20 mm length) corresponds approximately to the amount in three large bottles of standard-size mineral water and are significantly below the values of the Mg tablets taken as food supplements. Or as a Singaporean top scientist expresses it: “The body loves magnesium.”

Some Key ADVANTaGES OF USING MAGNEZIX® IMPLANTS

Ø 金属和可转化:MAGNEZIX®植入物逐渐在体内重新吸收,转化为内源性身体组织,同时提供稳定性和弹性,支持愈合过程。让第二次移除植入物的手术变得过时。

Ø 稳定性:MAGNEZIX®植入物是金属的,比传统的PGA或PLA可吸收植入物稳定好几倍。

Ø 骨传导性:据报道,镁植入物可以刺激骨生长,并转化为内源性骨组织。

Ø 抑制感染:镁降解会在植入物的周围环境中产生碱性抗菌环境,从而抑制细菌生长。

Ø 生物相容性:合金成分无过敏史。

Ø 患者满意度:在非常成功的临床试验的三年随访中报告了100%的患者满意度,其结果被研究负责人归类为“耸人听闻的”。MAGNEZIX®植入物已经在全球许多国家进行了数千次成功的手术。

  • Infection inhibiting: Magnesium degradation creates an alkaline, anti-bacterial environment in the immediate surroundings of the implant that can inhibit bacterial growth.
  • Biocompatibility: No allergies are known for the components of the alloy. 
  • Patient satisfaction: 100% patient satisfaction has been reported in the three-year follow-up to the highly successful clinical trial, the results of which have been classified as “sensational” by the study leader. Many thousand successful surgeries with MAGNEZIX® implants have already taken place in many countries around the globe. 

MAGNEZIX® COMBINES THE
ADVANTAGES OF TWO WORLDS

Traditionally, implants made of steel or titanium or degradable polymers (based on sugar or lactic acid) are used for the temporary stabilization in many surgical restorations of bones after fractures and malalignments in the human skeleton. Although steel and titanium implants offer the stability required for bone healing, these often remain permanently in the body as foreign material and can lead to long-term problems, trigger allergies or foreign body reactions and have to be removed frequently in a second surgery. Implant removal surgeries are always associated with renewed surgical risks, especially vascular and nerve injuries, infections as well as renewed risk of anesthesia and pain. Moreover, there are numerous reports and publications on the toxicity and potential carcenogenity of titanium.

In the recent past, resorbable implant materials based on polymers (PLA/PGA) had established themselves in surgical medicine. Although polymer-based implants offer absorption, they lack sufficient load-bearing capacity and are found to be associated with foreign body reactions in a large number of patients, which seriously questions their good compatibility. Their stability is significantly inferior to that of metallic implants.

Magnesium-based degradable implants made of the revolutionary MAGNEZIX® material combine the mechanical strength of metal implants with degradability, and thus eliminate the need for a second surgery to remove the implants (as well as all the associated stress and risks (infection, anesthesia) associated with surgery). Thus, they combine the advantages of both types of conventional implants, and they even have significant strengths and advantages beyond.

MAGNEZIX® IMPLANTS ARE SUITABLE
FOR CT AND MRI DIAGNOSIS

MAGNEZIX® implants are metallic and suitable for MRI and CT diagnostics. Interference signals are greatly reduced in computer tomography (CT) and the implants generate very few artefacts. In addition, unlike conventional screws made of steel and titanium, implants made of MAGNEZIX® do not generate any noticeable temperature increases during common MRI scanning. This helps considerably improve the analysis of postoperative images by surgeons and radiologists.

 

Osteoconductive and infection inhibiting - MAGNEZIX®

Magnesium has been reported to have osteoconductive properties. Histological investigations showed bone formation at the surface of the implant as well as bone growth into the absorbed implant zones. MAGNEZIX® implants help reduce the risk of infection because they are delivered as sterile devices. Furthermore, the degradation of the implant via corrosion creates an alkaline, anti-bacterial environment in the immediate surroundings of the implant that can inhibit bacterial growth. 

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.