Boston Scientific announced that the US Food and Drug Administration (FDA) has approved the Spectra WaveWriter spinal cord stimulator (SCS) system.
It is the first and only system approved by the FDA to simultaneously provide paresthesia-based and sub-perception therapy. The system allows physicians and patients to combine therapeutic options, customize therapy and capture real-time feedback designed to treat chronic and debilitating pain successfully.
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. Patients provide real-time feedback using the system's remote control. Together, these features benefit patients by addressing each individual's unique pain relief needs.
The Spectra WaveWriter System was developed with more than a decade of clinical research focused on optimizing sub-perception and delivering multiple therapies intended for more effective, long-term pain relief. These studies include 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.
Boston Scientific neuromodulation senior vice president and president Maulik Nanavaty said: "We are introducing industry-leading SCS technology to help provide patients with lasting relief from chronic pain.
"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."