Boston Scientific Trial to Study Spinal Cord Stimulation
May 3, 2010
Boston Scientific has begun enrolling patients in a clinical trial to compare the therapeutic and cost-effectiveness of spinal cord stimulation (SCS) therapy to spine reoperation in patients with failed back surgery syndrome. The EVIDENCE trial will enroll 132 patients at 20 worldwide sites, and it is the first multicenter trial to include rechargeable SCS devices, the company says. The trial will examine treatment response rates — leg pain relief with no request for alternative therapy — at six and 24 months. Successful response is defined as greater than or equal to 50 percent pain relief.