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The world's first porous titanium alloy intervertebral fusion cage has been approved for launch Hay:P01XAWD

time:2023-10-11 browse:87903次


Recently, the hydroxyapatite coated porous titanium alloy intervertebral fusion cage developed by XAWD Biomedical Technology Corporation has obtained a Class III medical device registration certificate from the National Medical Products Administration (NMPA) of China.


It is reported that this is the world's first approved 3D printed porous titanium alloy intervertebral fusion cage with bioactive coating.


No need for additional bone grafting, simplifying surgical procedures


The porous titanium alloy intervertebral fusion cage launched by XAWD uses selective laser melting additive manufacturing (SLM) technology and vacuum plasma spraying technology to successfully construct a metal porous microstructure with bioactive surfaces. Compared with pure porous titanium alloy materials, it can more effectively promote early bone integration and long-term biological stability within the porous structure.


At the same time, the excellent bone conductivity and surface activity of the porous titanium alloy intervertebral fusion cage make it unnecessary for additional bone grafting inside the fusion cage like traditional fusion cages during clinical use. This not only greatly simplifies surgical operations, but also solves the problem of insufficient local bone extraction in minimally invasive spinal fusion surgery. The emergence of porous titanium alloy intervertebral fusion cages provides a better product choice for minimally invasive fusion surgery.


In addition, the porous titanium alloy intervertebral fusion cage also has excellent mechanical properties. Its unique truss+microporous structure achieves a balance between low elastic modulus and high fatigue performance, ensuring the immediate stability and long-term biomechanical stability of the fusion cage after implantation.


Research has shown that the elastic modulus of the porous structure of the porous titanium alloy intervertebral fusion cage decreases by 37% compared to PEEK material. The anti settlement performance of the porous titanium alloy intervertebral fusion cage is more than twice that of PEEK fusion cage, which can effectively reduce the probability of complications such as fusion cage settlement. And the dynamic fatigue performance of this product also reaches 2.6 times that of PEEK fusion, greatly increasing the safety performance of the product in complex mechanical environments inside the body.


Since 2019, this product has been conducting multicenter, prospective, and randomized controlled clinical trials at Xi'an Xijing Hospital, Chongqing Xinqiao Hospital, Bethune First Hospital of Jilin University, and Sino Japanese Friendship Hospital of Jilin University. The research results showed that the fusion effective rate of HA coated porous titanium alloy fusion cage at 6 months after surgery was 97.10%, which was higher than the fusion effective rate of PEEK fusion cage at the same time, which was 85.29%. No adverse events related to the product were observed during the trial period, We have achieved excellent clinical results.