The US Food and Drug Administration (FDA) has granted approval for an extended indication of Boston Scientific‘s WaveWriter SCS Systems.
This approval now encompasses the treatment of chronic low back and leg pain in individuals who haven’t undergone previous back surgery, a condition often denoted as non-surgical back pain (NSBP).
Carolinas Pain Institute MD and SOLIS trial principal investigator James North said: ″Diagnosing and treating chronic low back pain can be challenging.
″The new indication for NSBP expands the use of the WaveWriter SCS Systems to patients who have had limited options for treating their lower back pain.”
Boston Scientific said that the FDA’s decision is supported by the SOLIS randomised control trial.
The trial provided one-year data demonstrating that the WaveWriter SCS Systems met its primary endpoint of a 50% or greater reduction in pain at the three-month interval.
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The trial’s results indicate that the WaveWriter SCS Systems can deliver significant and sustained pain relief.
At the one-year mark, 84% of patients using the WaveWriter Systems experienced substantial pain relief, with a pain reduction of 50% or greater.
Boston Scientific neuromodulation president Jim Cassidy said: “Early and effective intervention with SCS therapy is associated with long-term success and improved outcomes for people living with chronic back pain.
“Today’s approval, combined with the recent indication for diabetic peripheral neuropathy, extends the reach of our robust portfolio to help physicians deliver individualised care across a wide spectrum of lower back pain issues.”
Recently, Boston Scientific reported GAAP net income attributable to the company’s common stockholders reaching $1.57bn for the full year 2023, an increase from $642m in the previous year.