New real-world findings assist the effectiveness and use of ReActiv8® Restorative Neurostimulation™ to deal with intractable continual low again ache
November 23, 2022
DUBLIN–( BUSINESS WIRE )– Mainstay Medical Holdings plc immediately introduced the publication of information from a real-world, single-center examine with one-year scientific follow-up of sufferers from the ReActiv8®-C examine. Sufferers who acquired ReActiv8 implants at Klinikum Itzehoe had been sequentially included on this cohort if they’d again ache ≥6 and no prior lumbar surgical procedure. The one-year outcomes, revealed within the journal World Neurosurgery , confirmed that almost all of the 44 sufferers who had been adopted had statistically important enhancements in ache (NRS), incapacity (ODI), and high quality of life (EQ-5D-5L).
This interim evaluation means that the response to ReActiv8 in these sufferers is sustained and advantages enhance over time, in step with each a restorative mechanism of motion and outcomes from the randomized scientific trial ReActiv8-B.
dr Med. Ardeshir Ardeshiri, Chief Doctor, Backbone Surgical procedure Part, Trauma Surgical procedure and Orthopedics Clinic, Klinikum Itzehoe, stated: “These constructive real-world knowledge are in step with the ReActiv8-B examine, which is extraordinarily essential to me when introducing new applied sciences. I look ahead to persevering with to supply restorative neurostimulation with ReActiv8 to my sufferers with multifidus dysfunction leading to continual axial low again ache.”
Jason Hannon, CEO of Mainstay Medical stated , “ These real-world outcomes validate the restorative mechanism of motion of ReActiv8, which addresses one of many main causes of mechanical continual low again ache, multifidus dysfunction. German physicians are among the many early adopters of ReActiv8 and we look ahead to making the remedy much more extensively out there to sufferers on this area.”
Hyperlink to Actual-World Proof for Restorative Neurostimulation examine publication in Persistent Low Again Ache—a Consecutive Cohort Examine – ScienceDirect
ReActiv8 is an implantable medical machine for the remedy of adults with refractory continual low again ache (CLBP) related to multifidus muscular dysfunction. Multifidus muscle dysfunction may be detected by imaging or physiological testing in adults who’re unresponsive to remedy, together with ache relievers and bodily remedy, and who’re ineligible for spinal surgical procedure. ReActiv8 has acquired regulatory approval in a number of geographic areas and is commercially out there within the European Financial Space, Australia, the UK and the US.
About Mainstay Medical
Mainstay Medical is a medical know-how firm centered on commercializing its revolutionary implantable Restorative Neurostimulation™ system, ReActiv8 ® , for sufferers with disabling mechanical CLBP. Mainstay Medical is headquartered in Dublin, Eire with subsidiaries in Eire, USA, Australia, Germany and the Netherlands.
Go to www.mainstaymedical.com for extra info.
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