Policy & Regulation
Boston passes US FDA's approval for non-opioid treatment option for chronic pain device, the Spectra WaveWriter Spinal Cord Stimulaor
12 January 2018 -

Medical solution company Boston Scientific Corporation (NYSE:BSX) reported on Thursday the receipt of approval from the US Food and Drug Administration (FDA) for the Spectra WaveWriter Spinal Cord Stimulator (SCS) System for the non-opioid treatment option with multiple therapies for people with chronic pain.

The company said the SCS System is the first and only system approved by the US FDA to simultaneously provide paresthesia-based and sub-perception therapy, allowing physicians and patients to combine therapeutic options, customise therapy and capture real-time feedback designed to treat chronic and debilitating pain.

According to the company, SCS works by sending low electrical pulses, which vary in 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.

In conjunction, the company's SCS System was developed with more than a decade of clinical research via the WHISPER and the PROCO studies, with focus on optimising sub-perception and delivering multiple therapies intended for more effective, long-term pain relief.

Concurrently, the company's PROCO was a multi-centre, prospective, double-blind, randomised study in which patients acted as their own control. This study established 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. The WHISPER is a multi-centre, prospective, cross-over, randomised and controlled study evaluating the long-term safety and effectiveness of sub-perception SCS pain relief therapy.

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