After implantation, ReActiv8 delivers electrical stimulation directly to the nerves responsible for those muscles. This nerve stimulation causes controlled muscle contractions. With regular use, muscle strength and control returns and spine stability improves, relieving low back pain at the source. WebFood and Drug Administration
FDA Approves New Implant for Treating Chronic Low Back Pain
WebThe recovery trajectory is consistent with a restorative mechanism of action and suggests that over the long term these health states will be maintained. ... have failed therapy including pain medications and physical therapy and (ii) are not candidates for spine surgery. ReActiv8 is a prescription device implanted by certified physicians in an ... WebThe ReActiv8 System is an implantable neurostimulation system proven to restore muscle control of the lumbar spine for improved low back pain management. During a minimally … north china restaurant chicopee
Physician Locator Main - Mainstay Medical
WebFeb 23, 2024 · Mainstay Medical’s ReActiv8 is a new implantable neurostimulation system designed specifically to treat chronic low back pain (Figure 3). ... and steroid injection and who are not good candidates for spinal surgery. “Previously, somebody in that circumstance for the most part was out of luck,” he says. A study of 53 patients who had ... WebMore specifically, ReActiv8 is indicated for bilateral stimulation of the L2 medial branch of the dorsal ramus as it crosses the transverse process at L3 as an aid in the management of intractable chronic low back pain associated with multifidus muscle dysfunction, as evidenced by imaging or physiological testing in adults who (i) have failed … WebJul 1, 2024 · ReActiv8 is intended for those patients without indications for spine surgery or spinal cord stimulation and who have continuing pain despite medical management. The Company currently estimates that there are approximately two million people in the EU and the U.S. who could be candidates for ReActiv8. north china restaurant