FDA approves Boston Scientific’s spinal cord stimulator system

15 January 2018 (Last Updated January 15th, 2018 09:53)

The US Food and Administration (FDA) has approved Boston Scientific’s Spectra WaveWriter Spinal Cord Stimulator (SCS) System for paresthesia-based and sub-perception therapy.

FDA approves Boston Scientific’s spinal cord stimulator system
Spectra WaveWriter Spinal Cord Stimulator System. Credit: Boston Scientific Corporation.

The US Food and Administration (FDA) has approved Boston Scientific’s Spectra WaveWriter Spinal Cord Stimulator (SCS) System for paresthesia-based and sub-perception therapy.

The system can be used to combine various therapeutic options, customise therapy and obtain real-time feedback for the successful treatment of chronic and debilitating pain.

SCS blocks pain signals by sending low electrical pulses of varied frequency, pulse width, and amplitude to the spinal cord.

While paresthesia-based therapy delivers pain relief with a light tingling sensation, sub-perception therapy works without this.

The Spectra WaveWriter system allows patients to combine these two therapies to target one specific pain area or they can use each therapy as needed to manage different areas of pain.

Boston Scientific Neuromodulation president and senior vice-president Maulik Nanavaty said: “We are introducing industry-leading SCS technology to help provide patients with lasting relief from chronic pain.

“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.”

The Spectra WaveWriter SCS System was clinically assessed in various studies such as WHISPER and PROCO to optimise sub-perception and provide different therapies for effective long-term pain relief.

Conducted to investigate the long-term safety and effectiveness of sub-perception SCS therapy, WHISPER is a multi-centre, prospective, cross-over, randomised, and controlled study.

The multi-centre and double-blind PROCO study, performed in de novo patients, is reported to have determined that pain relief and improvement in quality of life measures are not dependent on the frequency type in sub-perception therapy when correct target and dose are identified.