The US Food and Drug Administration has approved an Investigational Device Exemption (IDE) to allow evaluation of a high frequency electrical technology to treat residual limb pain in amputees.
Neuros Medical, Inc., a medical device company based in Cleveland, Ohio, will commence a pilot clinical trial to test the company’s patented high frequency Electrical Nerve Block for acute treatment of pain.
The IDE approval was based on the company’s successful feasibility study earlier this year, in which four out of five patients reported significant pain reduction, at times reducing pain scores to zero. The feasibility study was the first human test of the technology and focused on patients with chronic amputation pain, which affects nearly one million patients in the US.
“We are very pleased with the IDE approval and look forward to commencing the pilot study to provide longer term safety and efficacy data of our Electrical Nerve Block technology in a larger set of patients,” Jon J. Snyder, president and chief executive officer of Neuros Medical, stated in a press release.