Medovex Corp., a developer of medical technology products, announced that its DenerveX System has successfully been used in its most extensive live tissue test to date using the final pre-production model device and generator.
The company’s patented system, now in the final development stages and not yet commercially available, is designed to provide longer lasting relief of pain associated with the facet joint. Lower back pain is the second most common cause of disability in the U.S. for adults. Studies indicate that 10 percent of the U.S. adult population suffers from lower back pain and that 31 percent of lower back pain is attributed to facet joint pain.
The DenerveX Device Kit and Pro-40 generator was tested as a working system under rigorous conditions using the required federal and international standards. Good Laboratory Practice for Non-Clinical Laboratory Studies contain the highest federal standards that medical technology company’s must meet prior in submitting for regulatory approval in the U.S. and the European Union.
“We continue to work aggressively towards a future CE mark process and successful launch in the European Union and other countries that accept the CE mark globally,” Patrick Kullmann, president and COO, said in a statement. “This successful test paves the way towards the completion of the final set of testing and verification. The system used in this laboratory testing consisted of the latest pre-production model of the system that is the identical model to the device for human use.”
The system consists of the DenerveX, a single use device, and the DenerveX Pro-40 Power Generator. It is designed to provide a minimally invasive treatment option which combines two actions into one device. The combined procedure is expected to provide a longer lasting solution and potential savings to the health care system.
DenerveX system is not yet CE marked or FDA cleared and is not yet commercially available.
