Boston Scientific's Spectra WaveWriter spinal cord stimulator system gains FDA approval

Boston Scientific announced Thursday that its Spectra WaveWriter spinal cord stimulator (SCS) system gained FDA approval for the treatment of chronic pain. The company noted that the SCS system, which is "the first" FDA approved "to simultaneously provide paraesthesia-based and sub-perception therapy," allows doctors and patients to "combine therapeutic options, customise therapy and capture real-time feedback" to successfully treat chronic and debilitating pain.

According to Boston Scientific, with the system, patients can choose to combine paraesthesia-based therapy and sub-perception therapy to target one specific pain area or use each therapy as needed to best manage multiple pain areas. The company added that patients provide real-time feedback using the system's remote control.

Boston Scientific noted that the SCS system was developed with more than a decade of clinical research, including the WHISPER study, which is evaluating the long-term safety and effectiveness of sub-perception SCS pain relief therapy. Meanwhile the PROCO trial, in which patients acted as their own control, found that "that similar pain relief and improvement in quality of life measures are achieved independent of the type of frequency used in sub-perception SCS therapy when the proper target and dose are identified," the company said.