Boston Scientific secures expanded FDA approval for WaveWriter SCS systems
07 Feb 2024
The Spectra and Alpha versions of WaveWriter SCS systems were already approved in the US, and expanded indication facilitates the treatment of chronic low back and leg pain in people without prior back surgery, known as non-surgical back pain (NSBP)
WaveWriter Alpha spinal cord stimulation (SCS) system. (Credit: Boston Scientific Corporation)
US-based medical device company Boston Scientific has received the US Food and Drug Administration (FDA) expanded approval for the WaveWriter spinal cord stimulation (SCS) systems.
The Spectra and Alpha versions of WaveWriter SCS systems were already approved in the US.
The US health agency approved the Spectra WaveWriter SCS system in 2018 and WaveWriter Alpha SCS systems in 2020 to manage chronic intractable pain in the trunk or limbs.
The expanded FDA approval allows the use of WaveWriter SCS Systems to treat chronic low back and leg pain in people without prior back surgery, known as non-surgical back pain (NSBP).
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.”
The expanded FDA approval for WaveWriter SCS systems is supported by positive data from the SOLIS clinical study of SCS as an option for chronic low back or leg pain instead of surgery.
The randomised control trial met its primary endpoint at a three-month interval and showed that the WaveWriter SCS Systems provide significant and sustained pain relief.
In the one-year follow-up, the study showed that 84% of patients treated with the WaveWriter Systems reported significant pain relief of more than 50%.
Also, the patients experienced sustained improvement in their ability to perform daily activities, with a mean 25-point improvement in disability as measured by the Oswestry Disability Index.
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.”
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