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Boston Scientific: Pain Management Without The Pills


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

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.

The WHISPER study, a multi-center, prospective, cross-over, randomized, and controlled study, evaluates the long-term safety and effectiveness of sub-perception SCS pain relief therapy.

More than 100 million Americans suffer from chronic pain, which is the leading cause of disability in adults in the U.S. While prescriptions for opioids have quadrupled since 1999, the amount of pain reported in the U.S. has not changed.

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