The EU has given green light to Eden Spine, out of Lake Mary, Florida, to market the company’s Wellex device, described by its inventor, Dr. Jean-Marc Fuentes, as a “compressible dynamic extension controller that not only relieves pain but also positively affects the long-term health of the segment through its ability to dynamically control extension while protecting and maintaining the neutral zone.”
Biomechanically, the Wellex maintains flexion, axial rotation and lateral bending but, more importantly, is not an extension blocker. Rather, it controls extension dynamically, thereby positively affecting the neutral zone and reducing disc and facet loading. Multi-level implantations are possible.
“The Wellex Interspinous Process Technology aims at perfecting the balance between motion and stability by restoring the posterior tension band, the facet congruence and the foraminal height,” explained Mourad Ben Mokhtar, head of Eden Spine’s research and developments efforts. “Its unique characteristics establish it as the latest generation of extension controllers, positioning it to be the gold standard for spinal patients who do not respond positively to conservative treatment, who are not willing to suffer the consequences of a fusion, and who are in need of pain relief from spinal stenosis.”
Press release: Eden Spine Receives CE Mark for its Nonfusion Wellex(TM) Interspinous Process Medical Device
Eden Spine company page…
