- The U.S. Food and Drug Administration has approved Abbott’s spinal cord stimulation devices for the treatment of non-surgical back pain.
- Abbott landed the label expansion after showing its BurstDR spinal cord stimulation technology improved outcomes more than conventional medical management in people with chronic back pain who were ineligible for surgery.
- The label expansion comes 16 months after Nevro won FDA approval in non-surgical refractory back pain and four months after Boston Scientific released data on its rival device in the setting.
Abbott competes with Boston Scientific, Medtronic and Nevro for the spinal cord stimulation market and the four players are continually looking to expand into new areas where they are free from the intense competition that characterizes the core indications. Nevro unlocked an opportunity early last year, when it said it was the only company with specific labeling to treat non-surgical refractory back pain.
Now, Abbott has secured its own back pain label expansion.
The FDA approved BurstDR spinal cord stimulation devices in the new indication after reviewing data from Abbott's DISTINCT study, which enrolled 270 people who had lived with pain for 12.8 years, on average. Surgery was not an option for the study participants.
Most, 73%, of participants in the spinal cord stimulation study arm experienced a significant reduction in back pain, compared to 7.1% of patients who received conservative medical management. Abbott also found that 91% of people who received spinal cord stimulation therapy had significant pain relief or significantly improved function, and that recipients of its device experienced a 70% reduction in pain, on average.
Based on comments from Nevro, Abbott is entering a market that is still in its infancy. UnitedHealthcare excluded non-surgical back pain from its coverage of spinal cord stimulation devices late last year, and Nevro CEO Keith Grossman has told investors to expect the opportunity to “play out over time” and “require ongoing follow-up from [the company’s] study” and “competitors jumping in and driving this as well.”
Nevro now has two-year data from its non-surgical back pain clinical trial. Grossman told investors the publication of the data will enable the company “to more fulsomely engage with commercial carriers about the benefits” of its spinal cord stimulation device in the indication.
Shares in Abbott were little changed on Wednesday, falling 0.5%, or 57 cents, to $108.82.
Updates to add share price.