Originally published in our sister publication, Pain Medicine News.
The FDA has approved the Premarket Approval application for ReActiv8 (Mainstay Medical), an implantable neurostimulation system indicated to treat low back pain (LBP).
The approval is for intractable chronic LBP associated with multifidus muscle dysfunction, as demonstrated by imaging or physiologic testing in adults who have failed therapy, including pain medications and physical therapy, and are not candidates for spine