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News & Media

Part 1: ReActiv8 for Chronic Low Back Pain – Paul Christo MD

Aches and Gains Podcast

Part 2: ReActiv8 for Chronic Low Back Pain – Paul Christo MD

Aches and Gains Podcast

Man, 64, Lived With Back Pain for Decades. A New Treatment Changed His Life

Today

Phone: +1 (877) 702 8488

 

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* The ReActiv8-B Trial demonstrated a strong safety profile for the ReActiv8 system (particularly when compared to spinal cord stimulator devices). Among the 204 randomized patients, 8 serious adverse events (SAEs) related to the device/procedure were reported (4 percent overall) at the 120-day mark. There were no unanticipated SAEs related to the device/procedure, and notably no instances of lead migration. (Among all adverse events, both serious and non-serious, 53 percent occurred within the first 30 days; 83 percent of all related adverse events were resolved.)

The 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 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 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 outpatient setting. Patients should talk to their health care provider to discuss whether ReActiv8 is right for them.

To learn more about Mainstay Medical, important ReActiv8 safety and product information, visit:  www.mainstaymedical.com.