23 November 2022 - - Data from a single center, real-world study with one-year clinical follow-up of patients selected from the ReActiv8-C study has been published, Dublin-based medical device company Mainstay Medical Holdings plc said.

Patients implanted with ReActiv8 at Klinikum Itzehoe were consecutively included into this cohort if they presented with back pain ≥6 and no prior lumbar surgery.

The one-year results, published in World Neurosurgery, showed that a majority of the 44 patients followed up with demonstrated statistically significant improvements in pain, disability and quality of life (EQ-5D-5L).

This interim analysis indicates that the response to ReActiv8 for these patients is durable and the benefits improve over time, consistent with both a restorative mechanism of action and the ReActiv8-B randomized clinical trial results.

ReActiv8 is an implantable medical device designed to treat adults with intractable chronic low back pain 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.

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.