Neuros Medical, Cleveland, Ohio, announced that it has received an Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) allowing it to commence a pilot clinical trial to evaluate the company’s patented high-frequency Electrical Nerve Block™ technology for use in the treatment of pain in the residual limb of amputees.
The IDE approval builds off of the company’s first-in-man feasibility study last year, in which four out of five patients reported significant pain reduction, at times reducing pain scores to zero. The feasibility study focused on patients with chronic amputation pain.
“We are very pleased with the IDE approval and look forward to commencing the pilot study,” said Jon J. Snyder, president and CEO of Neuros Medical.
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