FDA system for treating pain without opioids
According to the medical device maker, the SCS system is the first and only system approved by the FDA to simultaneously provide paresthesia-based and sub-perception therapy.
SCS is designed to deliver low electrical pulses of varying frequency, pulse width and amplitude, to the spinal cord to interrupt pain signals.
Paresthesia-based therapy provides pain relief with a light tingling sensation, while sub-perception therapy works without that sensation.
The system will enable physicians and patients to combine both therapies, customize therapy and deliver real-time feedback to treat chronic and debilitating pain successfully.
SCS was developed by Boston Scientific after more than a decade of clinical research focused on optimizing sub-perception and delivering multiple therapies intended for effective, long-term pain relief. These studies include the WHISPER study and the PROCO study.
The multi-center, prospective, double-blind, randomized PROCO study established in de novo patients 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. ■