WebReActiv8 is designed to electrically stimulate the nerves responsible for contracting these muscles and thereby help to restore muscle control and improve dynamic spine stability, … WebJun 30, 2024 · Costs of the ReActiv8. Though costs of the device were not reported, costs of device and initial surgery are most likely substantial and at some point the device will have to be removed and/or replaced. This will require a subsequent surgery due to limited battery life. Some adverse events related to the subsequent surgeries are sure to occur.
ReActiv8 Neurostimulator Treats Cause of Back Pain, Now FDA
WebMay 25, 2024 · The ReActiv8-A trial was prospective single arm clinical trial with the purpose of collecting performance and safety data on a new implantable restorative … WebNov 15, 2013 · Suitable for ReActiv8 surgery as determined by the implanting physician prior to inclusion. Prior week average Low Back Pain NRS of ≥6.0 and ≤9.0 on a 11 point NRS scale (0-10) at the Baseline Visit Exclusion Criteria: BMI > 35 Back Pain characteristics: general and i characters
Mainstay Medical Announces U.S. FDA Approval of ReActiv8 ...
WebSep 8, 2024 · The ReActiv8 Implantable Neurostimulation System is intended to help with the management of chronic low back pain associated with the muscular weakness of the … WebMar 3, 2024 · Aurora Spine has announced that it has received Institutional Review Board (IRB) approval for its new multicentre study of its DEXA-C cervical interbody system, which is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular … WebDec 21, 2024 · ReActiv8-B trial (Gilligan et al [2024]): a randomized doubled-blind sham-controlled trial conducted across 26 sites in the US, Australia, and Europe; patients were 22 to 75 yr of age, diagnosed with chronic low back pain during at least 50% of days of the previous year, failed 90 days of conservative management, and had positive prone ... general anderson csa