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FDA system for treating pain without opioids

Staff Writer |
Boston Scientific Corp. (BSX) said that the U.S. Food and Drug Administration (FDA) has approved the Spectra WaveWriter Spinal Cord Stimulator or SCS System, which offers non-opioid treatment with multiple therapies for people with chronic pain.

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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.


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