Germany-based medical device firm joimax has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its Endoscopic Lumbar Interbody Fusion or EndoLIF On-Cage implant.
The approval allows use of the 3D-printed fusion implant during open and endoscopic-assisted spine surgery.
EndoLIF On-Cage features titanium alloy that is produced with electron beam melt (EBM) technology. It includes a porous surface with diamond cell structure, offering an optimal base for cell proliferation and bone growth.
joimax CEO and founder Wolfgang Ries said: "With the EndoLIF program, joimax offers a complete endoscopic-assisted solution for spinal stabilization and fusion. In the future, we will be able to treat patients with even more gentle techniques.
"Our next development will be an EndoLIF Cage on the basis of our iLESSYS Delta system for posterior lumbar inter-body fusion (PLIF)."
The implant helps surgeons to use an inter-muscular approach, similar to a mini transforaminal lumbar interbody fusion (TLIF), into the intervertebral disc, allowing to carry out endoscopic-assisted fusion.
EndoLIF On-Cage has been designed to use with supplemental posterior fixation such as joimax Percusys percutaneous pedicle screw-rod system.
Through using an open or endoscopic-assisted method, the cage implantation can be carried out with a posterior or postero-lateral approach.
Image: joimax’s 3D-printed fusion implant EndoLIF On-Cage. Photo: courtesy of Business Wire.