Neuros Medical Inc. said it received an investigational device exemption from the FDA to run a clinical trial of its Altrius implantable generator to treat chronic pain in amputees.
The Altius device, consisting of an electrode and a generator, uses Neuros Medical’s patented electrical nerve block technology to deliver high-frequency stimulation to the peripheral nervous system to block chronic pain.
The Willoughby, Ohio-based company said a long-term pilot study showed that 7 of 9 patients experienced a significant reduction in pain when using an external generator. The new study will examine an implantable generator, Neuros said.
“We are extremely pleased with the IDE approval and look forward to converting the pilot study participants to the Altius implantable device, continuing to provide long-term pain relief to those suffering from chronic amputation pain,” president & CEO Jon Snyder said in prepared remarks.