|Mourad Ben Mokhtar speaks about the WELLEX™|
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Subject: Launch of the Wellex™ Interspinous Dynamic Stabilization System
Date Published: May, 2009
Mourad Ben Mokhtar has been the President of Eden Spine Europe SA, located in Geneva Switzerland, since its creation in 2005. During that time, he has managed the development of several cutting edge spinal innovations in the high growth market of Dynamic Spinal Systems, including the Wellex™ Interspinous Dynamic Stabilization Technology. Eden Spine Europe SA is a wholly owned subsidiary of Eden Spine LLC, based in Lake Mary (Orlando), Florida, USA.
Mr. Ben Mokhtar, removing back pain without removing spinal motion seems to be your “motto.” What inspired you to develop the Wellex™ Interspinous Dynamic Stabilization Technology?
In 2005, we knew that interspinous technologies would become a key area in the treatment of degenerative disc disease, as they had the potential to fill the gap between conservative, les effective care and riskier fusion. However, as a biomechanical engineer, I also knew that existing interspinous technologies simply acted as extension blockers, did not comply with the dynamic nature of the spine, and often resulted in “poor” longer term clinical results.
The inspiration for the Wellex™ was the result of our scientific collaboration with Dr. Fuentes, a renowned Neurosurgeon from France. Using the power of “imagination” and sharing our engineering expertise with his clinical experience, it became obvious to us that the ideal solution was a technology that did not block extension, but controlled it dynamically in a customizable fashion. The concept of the Wellex™ Interspinous Dynamic Stabilization technology was born in 2006!
As Dr. Fuentes stated on multiple occasions, the Wellex™ is a reliable spinal system that not only relieves pain, but also positively impacts the long term health of the segment through its ability to dynamically control extension while protecting and maintaining the neutral zone.
What has been the reaction to the Wellex™ within the medical community?
It has been tremendous… After 2 years of development, the Wellex™ obtained CE Mark in October 2008, was officially launched at the Spine Arthroplasty Society meeting in May 2009 in London. It is being successfully implanted in patients as we speak. Distribution agreements are being executed in multiple markets around the globe outside of the US, and surgeons seem to adhere to the concept and its potential to improve patient care.
What kind of impact do you see the launch of the Wellex™ having on the Dynamic Stabilization market?
We believe that the technology is the solution of choice for patients who are unresponsive to conservative spinal treatment, are not willing to suffer the consequences of a fusion, but are in need of pain relief from spinal stenosis.
Considering the ever growing patient population suffering from degenerative disc disease and more specifically spinal stenosis, and considering that we are the only interspinous technology that is truly dynamic and customizable to the patient’s morphology, we are confident that our impact on the dynamic stabilization market will be substantial as we intensify our global distribution network and gather valuable clinical data through our clinical studies.
How are you validating the technology?
We are true believers of “evidenced based” medicine, which is why “Clinical Studies” are already in the works. In addition, daily scientific and operating room monitoring is also a key ingredient to our R&D philosophy. To achieve this goal, we have put in place the “Wellex™ Advisory Panel,” composed of experts from several countries monitoring the launch of the technology and providing Eden Spine with clinical data, and participating in post-market surveys (PMS)