The DenerveX System, which has recently received CE Mark approval and clearance for commercialization in European countries, is a new device designed for enduring relief of Facet Joint Syndrome related to lower back pain.
“Our first human use cases for the DenerveX System took place in Manchester, England, recently with very encouraging initial procedural success," said Jarrett Gorlin, Medovex CEO. "We anticipate performing up to as many as 30 plus additional procedures by the end of August. This is the beginning of delivering on our goal of ‘proof of principle’ in the adoption of the technology in this very sizable market. We are also pleased to have also reached our first revenue events in the EU with others soon to expected to follow.”
The DenerveX System offers a fast and simple way to perform a safe Facet Joint Syndrome treatment.
“With the DenerveX System, we can offer surgeons and pain management specialists the ability to attain precise treatment of the Facet Joint pain. The DenerveX treatment uses ‘Rotacapsulation,’ a combination of high heat and rotational capsular tissue shaving, in a minimally invasive posterior procedure for the treatment of Facet Joint Syndrome," added Patrick Kullmann, Medovex president and chief operating officer. "The DenerveX System offers an alternative to existing treatments only providing temporary relief.”
Facet Joint Syndrome (FJS), also known as spinal osteoarthritis, spinal arthritis, or facet joint osteoarthritis, is a significant health and economic problem in the United States and other countries worldwide, affecting millions each year. Current treatment options are generally temporary and there is no proven long-lasting option for FJS.
The DenerveX System is a highly differentiated technology. It denervates and removes capsular tissue from the Facet Joint in one single procedure. Treatment results from the combined effect of a deburring or polishing action and RF ablation treatment on the Facet Joint. Using this new technique, the slowly rotating burr removes the targeted facet joint synovial membrane and joint surface while the heat ablation destroys tissue and denudes any residual nervous and synovial membrane overlying the joint, removing the end point sensory tissue of the joint.
The DenerveX System consists of the DenerveX Kit, which contains the DenerveX Device, a single use medical device and the DenerveX Pro-40 Power Generator. DenerveX system is not yet cleared by the U.S. Food and Drug Administration.
Medovex was formed to acquire and develop a diversified portfolio of potentially ground breaking medical technology products. Criteria for selection include those products with potential for significant improvement in the quality of patient care combined with cost effectiveness. The company’s first pipeline product, the DenerveX device, is intended to provide long lasting relief from pain associated with facet joint syndrome at significantly less cost than currently available options.