Mainstay Medical today announced that the United States Centers for Disease Control and Prevention (CDC) has designated an International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) diagnosis code specifically for multifidus dysfunction in the low back. The new diagnosis code - M62.85: dysfunction of the multifidus muscles, lumbar region - went into effect on October 1, 2024.
In response to an acute injury in the low back, the brain typically reduces the neural drive that activates the multifidus muscle, resulting in reduced multifidus activity. Because the multifidus muscle is a primary stabilizer of the lumbar spine, this inhibition can lead to joint instability and overload, exacerbating the problem and contributing to chronic low back pain (CLBP). The ReActiv8® Restorative Neurostimulation™ system is designed to provide electrical stimulation to the nerves activating the multifidus muscle, aid in restoring its function and facilitate recovery from CLBP. ReActiv8 is the only FDA-approved treatment for the management of intractable CLBP associated with multifidus muscle dysfunction.
"The CDC has recognized multifidus muscle dysfunction as a prominent cause of CLBP and is now providing clinicians a clearer pathway to specifically diagnose this condition. Multifidus dysfunction is a highly specific disease state that does not respond to palliative forms of stimulation, and we are excited that this new code provides for clear reflection of the underlying disease state," stated Jason Hannon, Chief Executive Officer of Mainstay Medical.
About ReActiv8®
ReActiv8 is an implantable medical device designed to treat adults with intractable chronic low back pain (CLBP) associated with multifidus muscle dysfunction. Multifidus muscle dysfunction may be evidenced by imaging or physiological testing in adults who have failed therapy including pain medications and physical therapy, and who are not candidates for spine surgery. ReActiv8 has received regulatory approval in several geographic areas, and is commercially available in the European Economic Area, Australia, the UK, and the US.
About Mainstay Medical
Mainstay Medical is a medical device company focused on commercializing its innovative implantable Restorative Neurostimulation system, ReActiv8, for people with disabling mechanical CLBP. Mainstay Medical is headquartered in Dublin, Ireland and has subsidiaries operating in Ireland, the United States, Australia, Germany, and the Netherlands.
