Thursday, July 25, 2024

Boston Scientific’s WaveWriter™ Spinal Cord Stimulator Receives FDA Approval for Nonsurgical Back Pain

by BIZ Magazine

Willis Knighton Health has announced that the U.S. Food and Drug Administration (FDA) has granted approval for Boston Scientific’s WaveWriter™ Spinal Cord Stimulator System for the treatment of nonsurgical back pain (NSBP). This milestone follows positive one-year results from a randomized controlled trial conducted at Willis Knighton Health and other sites across the United States.

The trial, which included participation from leading physicians at Willis Knighton Health’s Spine & Pain Specialists, was led by principal investigator Dr. John Noles. Sub-investigators Drs. David Hirsch, Russell Stuermann, and Nancy Germany, along with several healthcare professionals, contributed to the study. Ryan Wilkerson served as the clinical research coordinator.

Spinal cord stimulation has traditionally been utilized to address chronic and severe back and leg pain following lumbar spine surgery. Dr. Noles emphasized the therapy’s effectiveness in post-surgical patients, citing multiple robust studies supporting its efficacy. However, the FDA approval marks a significant expansion of the WaveWriter™ system’s indications to include patients with nonsurgical back pain who have had limited treatment options.

Results from the trial revealed promising outcomes, with 84 percent of patients experiencing pain relief of 50% or more and sustained improvement in daily activities after receiving WaveWriter™ treatment.

During the study, patients aged 18 and older with chronic back pain and no history of surgery were assigned to either a control group receiving standard care or an experimental group receiving spinal cord stimulation. Those in the control group had the option to switch to the WaveWriter™ device after three months.

Similar to a pacemaker, the WaveWriter™ system delivers mild electrical pulses to specific nerves along the spinal cord, intercepting pain signals before they reach the brain.

Chronic back pain affects a significant portion of the U.S. population, with approximately 72.3 million adults currently experiencing this condition. Conventional interventions such as physical therapy and medication often yield diminishing returns or result in adverse side effects, prompting the need for alternative therapies like spinal cord stimulation.

Dr. Noles expressed pride in Willis Knighton Health’s contribution to the groundbreaking study, highlighting the collaborative effort with Boston Scientific and leading physicians nationwide. “We are excited to offer more effective treatment options to our patients suffering from chronic low back and leg pain,” said Dr. Noles.

The FDA approval of the WaveWriter™ Spinal Cord Stimulator for nonsurgical back pain represents a significant advancement in pain management, offering hope to millions of individuals seeking relief from debilitating symptoms.

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