The Spectra WaveWriter Spinal Cord Stimulator (SCS) System has received marketing approval from the US Food and Drug Administration, according to an announcement from Boston Scientific Corporation.
The system is engineered to allow physicians and patients to combine therapeutic options, customize therapy, and capture real-time feedback designed to treat chronic and debilitating pain successfully without the use of opioids.
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. With the Spectra WaveWriter System, patients can choose to combine both of these therapies to target one specific area of pain or use each therapy as needed to best manage multiple areas of pain, explains a media release from Boston Scientific Corp.
“Patients suffering with chronic pain experience pain differently, and pain also evolves over time, sometimes causing a patient to become less responsive as the body becomes accustomed to treatment,” says Dr Giancarlo Barolat, neurosurgeon, Barolat Neuroscience, Denver, Colorado, in the release. “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.”
The Spectra WaveWriter was developed as the result of clinical research, including the WHISPER study and the PROCO study.
The PROCO study was a multi-center, prospective, double-blind, randomized study in which patients acted as their own control. This 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 (from 1 kHz up to 10 kHz) used in sub-perception SCS therapy when the proper target and dose are identified.
The WHISPER study is a multi-center, prospective, cross-over, randomized, and controlled study evaluating the long-term safety and effectiveness of sub-perception SCS pain relief therapy.
According to a separate news release from Boston Scientific, data from the WHISPER study demonstrates that patients who are given the choice to use both sub-perception and paresthesia-based spinal cord stimulation (SCS) therapy achieve superior outcomes in comparison to patients who have only one SCS therapeutic option.
“We are introducing industry-leading SCS technology to help provide patients with lasting relief from chronic pain,” states Maulik Nanavaty, president and senior vice president, Neuromodulation, Boston Scientific, in the Spectra release. “We are committed to investing in research and expanding treatment options for chronic pain by identifying new, non-opioid solutions for the millions of people suffering from this debilitating condition.”
[Source(s): Boston Scientific Corporation, PR Newswire]