Dive Brief:
- Boston Scientific has won approval for its Wavewriter spinal cord stimulator (SCS) systems in non-surgical back pain (NSBP).
- The U.S. Food and Drug Administration approval expands the label of the Wavewriter systems to cover the treatment of chronic low back and leg pain in people without prior back surgery. The company announced the approval on Tuesday.
- Nevro won FDA approval in non-surgical refractory back pain in early 2022, becoming the first company to enter the space, and Abbott followed up with authorization in NSBP in May.
Dive Insight:
Patients with chronic back pain have traditionally received physical therapy and medication when they first present with symptoms. However, patients can stop responding to the interventions or suffer side effects and have poor long-term outcomes. The limitations of traditional options have created a need for new ways to manage low back pain, the leading cause of disability globally.
SCS is an established option for patients who continue to experience chronic back pain after surgery. The technology has a shorter history of use in patients who are yet to undergo surgery, but Boston Scientific and its peers are working to expand into the population.
Boston Scientific’s expansion into NSBP is supported by one-year data from the Solis randomized control trial. The results showed that 84% of patients reported pain relief of 50% or more and a sustained improvement in their ability to participate in activities of daily living after receiving Wavewriter, according to the announcement. Patients had a mean improvement in disability of 25 points on the Oswestry Disability Index.
Approval for the new indication follows a fourth quarter in which Boston Scientific reported flat sales, on an organic basis, for its pain franchise.
Boston Scientific CEO Michael Mahoney told investors on an earnings call last week he expects performance “to improve in 2024.” The prediction is based on the recent launch of Wavewriter Alpha in diabetic peripheral neuropathy and the “strong real-world data” on Fast Therapy, a distinct SCS mechanism, presented at the North American Neuromodulation Society annual meeting, the CEO said.