Spinal Cord Stimulation With Precision® SCS System Versus Reoperation for Failed Back Surgery Syndrome

The EVIDENCE trial is a randomized controlled trial comparing the therapeutic effectiveness
and cost-effectiveness of the Precision® Spinal Cord Stimulation with that of reoperation as
a treatment of pain in patients with Failed Back Surgery Syndrome (FBSS). FBSS is defined
as persistent or recurrent pain following one or more lumbosacral spine surgical procedures.
Surgical procedures that can result in FBSS can be categorized as either decompression or
decompression followed by fusion with or without instrumentation. The pain of FBSS is
categorized as neuropathic, which involves pathological nerve activity and is commonly
characterized by patients as shooting or burning and/or nociceptive, which signals actual or
impending tissue damage or inflammation.

The co-primary study endpoints are proportion of subjects with ≥50% leg pain relief without
crossover at 6 and at 24 months.