Neuros Medical, Inc., a neuromodulation company based in Cleveland, OH, has received Investigational Device Exemption (IDE) approval from the FDA for its high frequency Electrical Nerve Block technology for use in acute treatment of residual limb pain in amputees.
The Electrical Nerve Block stimulator was covered previously on Medgadget. The implanted system consists of a pacemaker-like stimulus generator, lead wires and a cuff electrode which is placed around the target nerve as shown in the video. It is designed to eliminate chronic pain for a number of applications such as neuroma/residual limb pain, chronic post surgical pain and chronic migraine.
The IDE approval follows from Neuros Medical’s first in man feasibility study which demonstrated promising initial results earlier this year. According to the press release, a pilot study to provide longer term safety and efficacy data on a larger number of patients will be next step for this stimulating technology.
Press release: Neuros Medical Receives Regulatory Approval to Commence Pilot Study
Flashback: Neuros Medical’s Electrical Nerve Block Showing Significant Amputation Pain Reduction in Early Study
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