Boston Scientific is hopping on the bandwagon as the latest developer of a spinal cord stimulation system to receive FDA approval for diabetic neuropathy pain relief.
The newly handed-down regulatory nod went to the devicemaker’s WaveWriter Alpha spinal cord stimulators, which were initially approved in both the U.S. and Europe in late 2020 with an indication to help relieve chronic pain in the trunk and limbs.
The FDA’s expanded indication now allows the implants to target diabetic neuropathy in the lower extremities, in which high blood sugar levels in people with diabetes injure their nerves in the legs and feet, causing feelings of pain and numbness. According to data cited by Boston Scientific, around half of all U.S. adults living with diabetes—who currently number in the tens of millions—will experience painful diabetic neuropathy at some point.
“The use of SCS to support a subset of the diabetes population is an important advancement for one of the fastest growing chronic conditions in the world,″ Jim Cassidy, president of Boston Scientific’s neuromodulation division, said in a company announcement Wednesday. ″This expanded indication is another testament to our commitment to delivering a robust portfolio of interventional pain solutions that provides physicians with more treatment choices to help their patients find relief.”
Like other spinal cord stimulation systems, the WaveWriter Alpha technology centers around a small pulse generator that’s implanted near the spinal cord. It sends out mild electrical pulses through an attached lead to reach targeted nerves on the spinal cord, with an aim of interrupting the pain signals traveling between those nerves and the brain.
The WaveWriter Alpha portfolio comprises four separate systems featuring various combinations of the number of contact points embedded on the stimulator and both rechargeable and non-rechargeable options. All of the devices can safely stay implanted during MRI scans, and all are Bluetooth-enabled, allowing patients and doctors to adjust their therapy regimens as needed using a wireless remote.
The launch of the WaveWriter Alpha devices also saw Boston Scientific unveil its Fast-Acting Sub-perception Therapy, or FAST—which, as the name suggests, enables the implants to begin providing pain relief within just a few minutes of their initial programming.
Several other devicemakers have added diabetic neuropathy indications to their own spinal cord stimulators in recent years, with Abbott’s Proclaim XR hardware earning that expanded FDA approval earlier this year and Medtronic tacking it onto its Intellis and Vanta neuromodulation systems in early 2022.
The first of this string of approvals went to Nevro in mid-2021. Since then, the company has racked up plenty of data proving its Senza system’s success in treating painful diabetic neuropathy: Two-year study results published this summer showed that 142 people implanted with the rechargeable device had experienced an average pain reduction of nearly 80%, and almost 90% of the participants saw their pain levels cut at least in half after two years of use.