LAKE MARY, Fla., Oct. 7, 2008 — Eden Spine (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.”
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.
As a technology driven organization, Eden Spine LLC, a privately held spine company headquartered in Lake Mary, Florida, is positively impacting patient care and creating substantial value developing tomorrows’ spinal technologies and building a world class spine franchise, inclusive of a fiscally responsible sales & distribution network. The Eden Spine Group is commercially active in the United States, Europe, the Middle East and Latin America. The company possesses 5 proprietary technologies including three new-generation, motion preservation technologies; the WellDisc™ total disc replacement; the Perfx-2™ Dynamic Stabilization System, and the Wellex™ Interspinous Technology. Eden Spine currently distributes a range of FDA-cleared and CE Marked spine technologies in the US and internationally.
Contact: Guillaume Viallaneix, CEO, 407-792-2279, G.Viallaneix@EdenSpine.com