WebJun 30, 2024 · The ReActiv8. The FDA recently approved an implantable neurostimulation system called the ReActiv8 to treat low back pain due to spinal muscle dysfunction. The device is surgically placed in the lumbar area to electrically stimulate a nerve that causes contraction of the lumbar multifidus muscle, a stabilizing muscle in the low back. WebMay 25, 2016 · “ReActiv8 is an innovative use of neurostimulation for the treatment of chronic low back pain and the clinical data from the ReActiv8-A trial are compelling.
Mainstay Medical Announces U.S. FDA Approval of ReActiv8
WebJun 22, 2024 · The FDA approval of ReActiv8 is primarily based on results from the ReActiv8-B clinical study, a pivotal 204-patient, international, multi-center, prospective, randomized, active sham-controlled ... WebMar 29, 2024 · The Reactiv8 device was initially evaluated in an uncontrolled study, Reactiv8-A, which included 53 individuals with chronic (at least 90 days) low-back pain who had not obtained satisfactory pain relief with physical therapy or medication and were not eligible for spinal surgery or spinal cord stimulation (SCS). how to determine perimeter from area
ReActiv8 Neurostimulation Device May Relieve Chronic Low Back Pain …
WebReactiv8 hosted an amazing networking and stakeholder event today! Thank you to all those that attended. it was a pleasure meeting you all and we look forward… Michelle Crook on … WebJun 23, 2024 · According to the Company, ReActiv8 provides bilateral electrical stimulation of the L2 medial branch of the dorsal ramus nerve as it crosses the transverse process at L3. The stimulation elicits... WebThe ReActiv8 System is an implantable neurostimulation system that employs a restorative therapy designed to restore muscle control of the lumbar spine for improved low back pain management. More specifically, ReActiv8 is indicated for bilateral stimulation of the L2 medial branch of the dorsal ramus as it crosses the transverse process at L3 ... how to determine percentage rate and base