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FDA system for treating pain without opioids

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Staff Writer | January 12, 2018
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.
Spectra WaveWriter
America   Spectra WaveWriter Spinal Cord Stimulator
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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