Boston Scientific receives FDA approval for non-opioid painkiller
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Medical device maker Boston Scientific of Marlborough has received FDA approval for a new pain therapy system.
Boston Scientific announced Thursday it has received regulatory approval for a new treatment for chronic pain without the use of opioids.
The product, the Spectra WaveWriter Spinal Cord Stimulator System, is the first therapy product of its kind approved by the U.S. Food & Drug Administration, the Marlborough medical device company said.
Boston Scientific said the system works by sending low electrical pulses to the spinal cord to interrupt pain signals. The therapy provides pain relief with a light tingling sensation, a process called paresthesia-based therapy, and sub-perception therapy, which doesn't carry a sensation.
Patients can choose to combine both therapies to target one specific area of pain or use each therapy as needed to manage multiple areas of pain, the company said.
Boston Scientific did not say when the product might hit the market, or for what price. If successful, it could help alleviate the opioid epidemic, which has hit many Massachusetts communities hard. Experts have pointed to the over-prescribing of opioid medications such as OxyContin as one contributing factor.
The Spectra WaveWriter Spinal Cord Stimulator System has been developed for more than a decade of clinical research, the company said.
Boston Scientific also released its preliminary fourth-quarter and full-year financials this week.
Fourth-quarter sales were up 9.9 percent, surpassing $2.4 billion in unaudited numbers, the company said. For the year, sales topped $9 billion, an increase of 7.9 percent over the prior year.
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