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# Mainstay Medical Back Pain Device Approved
- URL: https://www.fdaweb.com/mainstay-medical-back-pain-device-approved/
- Published: 2020-06-23T12:00:00.000Z
- Updated: 2026-09-14T16:19:11.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5147069

FDA has approved a Mainstay Medical Holdings PMA for ReActiv8, an implantable neurostimulation system to treat intractable chronic low back pain. Approval was based on clinical data demonstrating that the device therapy provides “progressive improvements in pain and disability over time, both in magnitude of effect and the proportion of patients who benefit from the treatment,” the company says. It is designed for those suffering from musculoskeletal pain and does not compete with other forms of neuromodulation such as spinal cord stimulation, it says.

The company says the implant provides bilateral electrical stimulation of the L2 medial branch of the dorsal ramus nerve as it crosses the transverse process at L3\. “This nerve supplies the lumbar multifidus muscle, a key stabilizing muscle of the low back,” it says. “Reactiv8’s stimulation of the nerve elicits contraction of the muscle, which can lead to improvement in chronic lower back pain and its disabling effects.”