In a news release last week, Boston Scientific Corporation, Marlborough, MA, announced FDA approval for its Spectra WaveWriterTM Spinal Cord Stimulator (SCS) for the management of chronic pain. The Company describes it as “…the first and only system approved by the FDA to simultaneously provide paresthesia-based and subperception therapy.” SCS delivers electrical pulses of varying frequency, pulse width, and amplitude to the spinal cord to interrupt pain signaling. Paresthesia-based treatment is accompanied by a tingling sensation, while subperception therapy is not. The newly approved product enables patient and provider selection or combination of therapy modes, with real-time feedback on effectiveness captured via remote control.
Commenting on the technology, Giancarlo Barolat, MD, of Barolat Neuroscience, Denver, said “The main advantage of the Spectra WaveWriter System is that it integrates multiple therapies into a single device so that treatment can more easily be tailored to individual needs." Findings from 2 multicenter, prospective, double-blind, randomized studies were engaged to optimize the delivery of subperception SCS and enable the multiple therapy capabilities of the Spectra WaveWriter System, according to the Company. Maulik Nanavaty, president and senior vice president, Neuromodulation, Boston Scientific, summarized “We are committed to investing in research and expanding treatment options for chronic pain by identifying new, nonopioid solutions for the millions of people suffering from this debilitating condition."
Read the company press release announcing the approval.
Posted on January 16, 2018