Multifidus muscle

Mainstay Medical Announces Publication of Post-Market Clinical Trial Data from Ongoing ReActiv8®-C Study in Chronic Low Back Pain Patients

Retrieved on: 
Tuesday, November 22, 2022

Mainstay Medical Holdings plc today announced the publication of data from a single center, real-world study with one-year clinical follow-up of patients selected from the ReActiv8-C study.

Key Points: 
  • Mainstay Medical Holdings plc today announced the publication of data from a single center, real-world study with one-year clinical follow-up of patients selected from the ReActiv8-C study.
  • 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.
  • I am excited to continue offering restorative neurostimulation with ReActiv8 for my patients with multifidus dysfunction resulting in chronic axial low back pain.
  • ReActiv8 is an implantable medical device designed to treat adults with intractable chronic low back pain (CLBP) associated with multifidus muscle dysfunction.

Mainstay Medical Announces Publication of Three-Year Patient Outcomes Data from ReActiv8-B Clinical Trial Demonstrating Long-Term Efficacy of ReActiv8® Restorative Neurostimulation™

Retrieved on: 
Wednesday, September 28, 2022

ReActiv8 therapy has proven to maintain effectiveness long-term and provides this challenging patient population with a safe and restorative solution.

Key Points: 
  • ReActiv8 therapy has proven to maintain effectiveness long-term and provides this challenging patient population with a safe and restorative solution.
  • ReActiv8 is an implantable medical device designed to treat adults with intractable chronic low back pain (CLBP) associated with multifidus muscle dysfunction.
  • 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.

United Kingdom National Institute for Health and Care Excellence (NICE) Publishes Interventional Procedure Guidance (IPG) for ReActiv8® Restorative Neurostimulation™

Retrieved on: 
Friday, September 23, 2022

ReActiv8 is currently the only technology offering restorative neurostimulation to the NHS for refractory mechanical chronic low back pain (CLBP).

Key Points: 
  • ReActiv8 is currently the only technology offering restorative neurostimulation to the NHS for refractory mechanical chronic low back pain (CLBP).
  • This new guidance will enable patients to have greater access to the therapy when previous treatment options have not proven successful.
  • This new guidance will allow more patients to gain access to ReActiv8 within the U.K. and further afield.
  • 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 Announces Publication of Two-Year Patient Outcomes Data from ReActiv8-B Clinical Trial Demonstrating Long-Term Efficacy of ReActiv8® Restorative Neurostimulation™

Retrieved on: 
Thursday, January 6, 2022

The ReActiv8-B trial patient cohort continues to be evaluated to generate additional data on longer-term efficacy.

Key Points: 
  • The ReActiv8-B trial patient cohort continues to be evaluated to generate additional data on longer-term efficacy.
  • ReActiv8 is an implantable medical device designed to treat adults with intractable chronic low back pain (CLBP) associated with multifidus muscle dysfunction.
  • 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.

Mainstay Medical Announces Appointment of Jeffrey Dunn and Eric Major to its Board of Directors

Retrieved on: 
Tuesday, December 14, 2021

Mainstay Medical Holdings plc today announced the appointment of two new independent members to the companys board of directors, Jeffrey Dunn and Eric Major.

Key Points: 
  • Mainstay Medical Holdings plc today announced the appointment of two new independent members to the companys board of directors, Jeffrey Dunn and Eric Major.
  • We are pleased to welcome these two transformational business leaders as new independent directors on the Board, said David Brabazon, Chairman of the Mainstay Board of Directors.
  • Both Jeff and Eric have strong track records of success leading medical device companies focused on back pain from the launch phase through maturity.
  • Mr. Dunn co-founded the company and served as its President, Chief Executive Officer and Chairman of the Board of Directors from 2008 until April 2021.

SPRINT® PNS System Demonstrates the Important Role of the Multifidus in Treating Recurrent Low Back Pain Following RFA

Retrieved on: 
Tuesday, March 2, 2021

In contrast, PNS of the medial branch nerve results in activation of the multifidus muscles, a key postural muscle in the spine.

Key Points: 
  • In contrast, PNS of the medial branch nerve results in activation of the multifidus muscles, a key postural muscle in the spine.
  • With use of the SPRINT PNS System, a majority of participants in the study saw clinically significant reductions in pain intensity following a 60-day treatment period, with commensurate improvements in functional outcomes.
  • The system has been studied extensively for low back pain, shoulder pain, post-amputation pain, and chronic and acute post-operative pain, and iscleared for use up to 60 days.
  • Our SPRINT PNS System fulfills a critical unmet need for a drug-free, surgery-free option for millions who suffer from chronic pain.