Atlanta-based Medovex successfully completed a live tissue test of its DenerveX System, adhering to FDA standards. The company reported this is the largest living tissue population test ever conducted.
Here are six key points:
1. The Good Laboratory Practice protocol testing involved a 12-porcine subject clinical analysis of the DenerveX System at zero days, 30 days and 60 days post procedure.
2. The study included 144 treatments, with 48 treatment sites initially evaluated.
3. Of those 48 treatment sites, 92 percent of the DenerveX System treatments reached the targeted facet joint treatment sites.
4. The researchers found no signs of neurodegeneration at the dorsal nerve roots and dorsal ganglia.
5. The DenerveX System includes the DenerveX device and DenerveX Pro-40 Power Generator, intended to be less invasive.
6. The system has not received a CE mark or FDA clearance, yet.