The approval enables the firm to check the safety and efficacy of the 60-electrode spinal cord stimulator system in humans
High-definition wireless stimulator by Micro-Leads. (Credit: GlobeNewswire / Micro-Leads Medical, Inc.)
Medical device technology company Micro-Leads has received FDA Investigational Device Exemption (IDE) approval for its high-definition spinal cord stimulation (HD-SCS) system.
The spinal cord stimulation system from Micro-Leads offers a new technique to treat chronic focal pain and neurological conditions by stimulating the lateral spinal cord route directly using a precise 60-electrode array device.
Due to device targeting and procedural constraints, traditional spinal cord stimulators are unable to treat this type of pain.
Micro-Leads founder and chief executive officer Dr Bryan McLaughlin said: “FDA approval of our HD-SCS pulse-generator and lead system is an exciting development in our high-efficiency dosing platform for chronic pain management.”
“Most neuromodulation devices today only have a 30% dosing efficiency, resulting in a need to significantly overstimulate the nervous system.
“Therapeutic and device-related complications from overstimulation include discomfort, pain, daily device recharging, and a larger implanted device battery.”
Dr McLaughlin added: “Our injectable technology reduces the stimulation dose required to treat by one-half.
“These high-efficiency dosing improvements provide a unique and unprecedented opportunity to treat chronic focal pains, migraines, and diseases where conventional spinal cord and peripheral nerve stimulators have failed.”
With the approval, Micro-Leads will soon begin the testing of its 60-electrode spinal cord stimulator system in humans.
Earlier this year, Micro-Leads discovered a significant 50% dosage reduction when beta-testing their upcoming needle-deployable directional stimulator device.