Boston Scientific wins FDA clearance for electric pulse system for nonopioid pain management

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The FDA cleared Boston Scientific’s first-of-its-kind electric pulse system designed to treat pain management without the use of opioids.

The FDA gave the green light to Boston Scientific’s first-of-its-kind electric pulse system designed to treat pain without the use of opioids.

Dubbed the Spectra WaveWriter, the spinal cord stimulator system (SCS) generates low electrical pulses that vary in frequency and pulse width and amplitude to the spinal cord to disrupt pain signals in a patient, the company said. With the new system, patients can combine paresthesia-based therapy that produces a light tingling sensation with sub-perception therapy that works without the sensation to target specific areas of pain, or it can be used to manage multiple areas of pain.

According to the Centers for Disease Control, more than 100 million Americans suffer from chronic pain and it is the No. 1 cause of disability in adults in the U.S. Treatment for pain management has primarily fallen on the use of opioids, which has led to an epidemic of opioid addiction in the country.

"Until now, the medical community has had limited options to offer personalized pain relief therapy to patients,” Giancarlo Barolat, M.D., a neurosurgeon at Barolat Neuroscience in Denver, said in a statement. “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 system was developed with more than a decade of clinical research that included the WHISPER study and the PROCO study. In the PROCO study, patients acted as their own control and established in de novo patients that similar pain relief and improvement in quality of life measures could be 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 evaluated the long-term safety and effectiveness of sub-perception SCS pain relief therapy.