Spectra WaveWriter Spinal Cord Stimulator System receives FDA approval


The Spectra WaveWriter Spinal Cord Stimulator (SCS) System (Boston Scientific) has received FDA approval. It is the first and only system approved by the FDA to simultaneously provide paraesthesia-based and sub-perception therapy. The system allows physicians and patients to combine therapeutic options, customise therapy and capture real-time feedback designed to treat chronic and debilitating pain successfully.

Paraesthesia-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.

“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 Giancarlo Barolat, neurosurgeon, Barolat Neuroscience, Denver, USA. “Until now, the medical community has had limited options to offer personalised pain relief therapy to patients. 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 System was developed with more than a decade of clinical research focused on optimising 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 multicentre, prospective, double-blind, randomised 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 1kHz up to 10kHz) used in sub-perception SCS therapy when the proper target and dose are identified. The WHISPER study is a multicentre, prospective, cross-over, randomised, and controlled study evaluating the long-term safety and effectiveness of sub-perception SCS pain relief therapy.

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


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