Abbott’s Spinal Cord Stimulation Systems Receives the US FDA’s Approval for Chronic Back Pain
- The US FDA has approved SCS devices for chronic back pain who have not had or are not eligible to receive back surgery. The approval was based on the (DISTINCT) study evaluating BurstDR SCS therapy in 270 patients
- The results from the first 200 patients demonstrated a back pain reduction at 6mos. that was sustained at 12mos. follow-up, 72.6% of people in the SCS study arm & 85.2% of those implanted achieved back pain reduction vs 7.1% in the conservative medical management arm
- 91.4% with SCS therapy reported pain relief or improvements in function with an avg. pain reduction of ~70%. Abbott's SCS portfolio incl. the recharge-free Proclaim SCS family & rechargeable Eterna SCS platform
Ref: PRNewswire | Image: Abbott
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