Medovex Announces Successful Largest Living Tissue Population Test to Date
Medovex conducted a successful live tissue test of the DenerveX™ System under the most stringent standards required by FDA and other regulatory agencies. The device is intended to treat pain associated with facet joint syndrome.
Study results indicate that the DenerveX System delivers its intended treatment and supports the type of reimbursement that the company has secured in Germany, its first targeted country.
The Good Laboratory Practice (GLP) protocol testing consisted of a 12-subject clinical evaluation of the DenerveX System in a porcine model at 0, 30- and 60-days post-procedure. The total subject pool included 144 treatments, of which 48 treatment sites were randomly selected and evaluated per the GLP.
Of the 48 evaluated treatments, 92% of the DenerveX System treatments reached their targeted facet joint treatment sites. Dorsal nerve roots and dorsal ganglia showed no evidence of neurodegeneration at the sites examined. No routinely-examined organs had changes interpreted to be related to the study, and all subjects survived the study to term without complication.
DenerveX System is not yet CE Marked or FDA cleared, and is not yet commercially available, though Medovex is establishing distribution channels.
Sources: Medovex Corporation; ORTHOWORLD Inc.