Eden Spine Receives CE Mark for its Nonfusion Wellex™ Interspinous Process Medical Device : "Our device fills the gap between conservative care and fusion surgery to treat early-stage degenerative disc disease." Guillaume Viallaneix, CEO, Eden Spine

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Eden Spine (http://www.edenspine.com) announced today that it has received CE Mark approval for its proprietary interspinous medical device, the Wellex™. Developed in collaboration with Dr. Jean-Marc Fuentes from France, the Wellex is based on two decades of clinical experience with nonfusion devices. “The Wellex is a compressible dynamic extension controller that not only relieves pain but also positively affects the long-term health of the segment,” said Dr. Fuentes, “through its ability to dynamically control extension while protecting and maintaining the neutral zone.”

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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

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."

"Considering that spinal stenosis is the number-one preoperative diagnosis for adults over 65 in the U.S., and that an aging population is the number-one reason for the increase in spinal stenosis, leading to projections that by 2026, 20 percent of the U.S. population—or 65 million people—will be over the age of 65, it is clear that the Wellex represents a significant opportunity for Eden Spine to positively impact patient care in the years to come," said Guillaume Viallaneix, CEO.

Eden Spine LLC, a privately held spine company, is creating shareholder value by simultaneously emphasizing Sales and R&D. As an R&D organization focused on motion preservation technologies, Eden Spine has developed three new-generation, nonfusion technologies—the WellDisc total disc replacement; the FX 1 Dynamic Rod; and, the Wellex Interspisous Technology. As a Sales & Marketing organization, Eden Spine distributes in the U.S. a comprehensive range of FDA-cleared fusion technologies.

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Guillaume Viallaneix
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