FDA approves WaveWriter stimulators for back pain in people who never had back surgery

Boston Scientific/WaveWriter Alpha SCS

The FDA widened WaveWriter's label to chronic low back and leg pain in patients without prior spine surgery. The approval rests on the SOLIS randomised trial, which met its 3-month goal and showed lasting relief at one year.

• 84% of patients had at least 50% pain relief at one year.
• Disability score improved by 25 points on average (Oswestry index).
• Lets doctors offer stimulation before, or instead of, back surgery.