FDA expands approval for spinal cord stimulator

Spine

The FDA has approved Boston Scientific's WaveWriter SCS Systems for treating chronic low back and leg pain in people without prior back surgery. 

Chronic back pain management in nonsurgical patients is often limited to conventional management such as physical therapy and medication. 

Better pain management could help lead to improved quality of life and reduced opioid usage among patients, according to a Feb. 6 press release. 

The expanded use by the FDA is backed by positive one-year data from a randomized control trial that demonstrated the WaveWriter SCS Systems provides significant and sustained pain relief.

After one year, 84% of patients treated with the WaveWriter Systems reported significant pain relief of more than 50% and sustained improvement in their ability to participate in daily activities.

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