FDA Clears Endoscopic Lumbar Interbody Fusion Implant From Joimax

German company Joimax, which makes minimally invasive technology for endoscopic spinal surgery, has earned 510(k) U.S. Food and Drug Administration clearance for its EndoLIF (endoscopic lumbar interbody fusion) on-cage implant.

The EndoLIF on-cage consists of titanium alloy produced with electron beam melt (EBM) technology. The cage displays a porous surface with diamond cell structure providing a base for cell proliferation and bone growth. Two large openings, which may be filled with autogenous bone, are meant to support the creation of a straight column for fusion.

The EndoLIF implant allows surgeons to utilize an inter-muscular approach, similar to a mini transforaminal lumbar interbody fusion (TLIF), into the intervertebral disc, enabling endoscopic-assisted fusion. Ralf Wagner, M.D., of the Ligamenta Spine Center in Frankfurt, Germany, and Bernd Illerhaus, M.D., of Orthopädisch-Neurochirurgisches Zentrum in Datteln/Recklinghausen, Germany, two German spine specialists, have performed more than 200 out of 600 EndoLIF procedures in Europe.
“The access is dura and nerve-gentle, preserves the dorsal bony structures and we can avoid scar tissue because of the stepwise tissue dilation,” said Illerhaus.

The EndoLIF on-cage is designed to be used with supplemental posterior fixation, such as Joimax’s Percusys percutaneous pedicle screw-rod system. Cage implantation can be performed with a posterior or postero-lateral approach, either using an open or endoscopic-assisted method, company officials report.

“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,” said Wolfgang Ries, CEO and founder of Joimax. “Our next development will be an EndoLIF cage on the basis of our Ilessys Delta system for posterior lumbar inter-body fusion (PLIF).”