Boston Scientific (NYSE:BSX) said today that it won pre-market approval from the FDA for its Spectra WaveWriter spinal cord stimulator for treating chronic pain.
Spectra WaveWriter is designed to deliver electrical pulses of varying frequency, pulse width and amplitude to the spinal cord. Marlborough, Mass.-based Boston Scientific touted the device as the U.S. market’s first and only such system designed to provide both paresthesia-based and sub-perception therapy.
Paresthesia is a low-level tingling sensation that accompanies SCS treatment for some patients; sub-perception therapy does not create paresthesia. Doctors and patients can fine-tune their treatment using either or both therapies and patients can deliver real-time feedback using a remote control, the company said.
“We are introducing industry-leading SCS technology to help provide patients with lasting relief from chronic pain,” neuromodulation senior vice president Maulik Nanavaty said in prepared remarks. “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.”
“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,” added Dr. Giancarlo Barolat of Denver’s Barolat Neuroscience. “Until now, the medical community has had limited options to offer personalized 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.”
