Boston Scientific Corporation (NYSE: BSX) today announced the start of patient enrollment in the EVIDENCE Clinical Trial, which compares the therapeutic effectiveness and cost effectiveness of spinal cord stimulation (SCS) therapy to spine reoperation in patients with failed back surgery syndrome (FBSS). The first patient was enrolled by Joseph Buwembo, M.D. and Krishna Kumar, M.D., F.R.C.S.C., at Regina General Hospital in Regina, Saskatchewan, Canada.
EVIDENCE is a randomized, controlled trial enrolling 132 patients at 20 sites worldwide. Patients in the SCS arm of the trial will receive the Boston Scientific Precision Plus™ Spinal Cord Stimulator System.
The trial will examine treatment response rates (leg pain relief with no request for the alternative therapy) at six and 24 months. Successful patient response is defined as having greater than or equal to 50 percent relief of pain in the lower extremities compared to pain levels prior to the intervention.
"The standard approach to patients who continue to have persistent back and leg pain after lumbosacral spine surgery has been to look for another surgical treatment," said Richard B. North, M.D., neurosurgeon at The Sandra and Malcolm Berman Brain and Spine Institute in Baltimore, and Principal Investigator of the trial. "Following the positive, single-center trial we conducted at Johns Hopkins, the EVIDENCE multi-center trial will provide important data on the comparative effectiveness of SCS versus surgical spine reoperation in the management of chronic pain in FBSS patients."
"Ultimately, this study may provide support to shift SCS earlier in the treatment paradigm for patients who suffer chronic pain resulting from FBSS," said Dr. Kumar. "EVIDENCE may also demonstrate the cost effectiveness of SCS compared to reoperation."
"The EVIDENCE trial is the first multi-center, randomized, controlled trial to include rechargeable SCS devices like the Precision Plus System," said Michael Onuscheck, Senior Vice President and President of Boston Scientific's Neuromodulation Division. "We are pleased to sponsor this groundbreaking trial, which will help physicians better understand the treatment options available to patients with FBSS."
Boston Scientific Corporation