Just as a rising tide is said to lift all boats, so too is a new FDA clearance expanding the reach of all of Boston Scientific’s WaveWriter spinal cord stimulation systems.
The devices—which include the Spectra and Alpha versions of the WaveWriter technology—were originally cleared in 2018 and 2020, respectively, to help manage chronic intractable pain in the trunk or limbs, including back pain that persists even after or because of a surgical procedure. Now, however, that indication includes treatment of chronic pain in the lower back and legs that’s not associated with a past surgery, Boston Scientific announced Tuesday.
The expanded FDA nod allows the WaveWriter devices to be offered as an alternative to current standard treatments for non-surgical back pain (NSBP), which include physical therapy sessions and potentially addictive opioid medications and don’t always work for all patients.
″Diagnosing and treating chronic low back pain can be challenging,″ James North, M.D., the principal investigator of a trial of the devices’ new indication, said in the announcement. ″The new indication for NSBP expands the use of the WaveWriter SCS Systems to patients who have had limited options for treating their lower back pain.”
Spinal cord stimulators like the WaveWriter implants are programmed to send out mild electrical pulses to specific nerves along the spinal cord, with a goal of blocking pain signals before they can reach the brain.
According to results presented at the North American Neuromodulation Society meeting last month, the North-led randomized study, which recruited a total of 128 patients, achieved its primary endpoint by the three-month mark. At that point, a total of 90% of patients treated with the WaveWriter technology reported at least a 50% improvement in their pain levels without an increased opioid dosage—a milestone achieved by just 8% of the control group, who had been treated with conventional medical management.
After that, patients in the control group were able to switch over to using a WaveWriter device; at the one-year mark, 85% of that crossover group reported a reduction of at least 50% in their pain levels, consistent with the one-year data from the original WaveWriter group.
“Early and effective intervention with SCS therapy is associated with long-term success and improved outcomes for people living with chronic back pain,″ Jim Cassidy, president of Boston Scientific’s neuromodulation business, said in Tuesday’s release. ″Today’s approval, combined with the recent indication for diabetic peripheral neuropathy, extends the reach of our robust portfolio to help physicians deliver individualized care across a wide spectrum of lower back pain issues.”
The other label expansion referenced by Cassidy was directed at the WaveWriter Alpha system last fall. In that case, Boston Scientific announced in October that the implants were newly cleared to help treat pain in the lower extremities caused by diabetic neuropathy—echoing similar nods for other spinal cord stimulators from Abbott, Medtronic and more in recent years.