FDA Approves Smallest Rechargeable Spinal Cord Stimulator
/By Pat Anson, PNN Editor
The Food and Drug Administration has approved a new spinal cord stimulator that’s being touted as the smallest implantable neuromodulation device of its kind on the market. Abbott’s Eterna stimulator can also be recharged wirelessly as few as five times a year, unlike other stimulators that need recharging daily or weekly.
Spinal cord stimulators (SCSs) are an invasive treatment of last resort for people with chronic back or leg pain. The devices are surgically implanted near the spine and connected to batteries placed under the skin. The implants send low-level electrical impulses into the spine to block pain signals.
Abbott says it developed Eterna after extensive studies with pain patients and healthcare providers, who wanted a smaller implant with less need for recharging.
Eterna utilizes the company’s BurstDR stimulation, which mimics the natural firing patterns of nerves to provide pain relief without the tingling sensation of other simulators.
"Abbott's low-dose BurstDR stimulation is clinically proven to reduce pain, improve people's ability to perform everyday activities, and reduce emotional suffering associated with pain," Timothy Deer, MD, president and CEO of the Spine and Nerve Centers of the Virginias, said in a statement provided by Abbott.
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"Until now, it wasn't available on a rechargeable device that was this small, and that only needs to be charged a few times a year. This makes a big difference in comfort for many patients who now can have access to the best of both worlds – a small, best-in-class rechargeable device with superior stimulation therapy."
Another advantage of the Eterna SCS system is that patients with the device can still have full-body MRI scans – a critical need for those who need access advanced imaging and diagnostics. The devices can also been monitored and programmed with a mobile app.
About 50,000 SCSs are implanted annually in the U.S. and their use is growing – in part because of the belief they’ll reduce the need for opioids and other pain therapies.
A recent study found that premise to be untrue. Researchers at the University of California San Francisco School of Medicine found that pain patients with stimulators did not reduce their use of opioids, epidurals, corticosteroid injections or radiofrequency ablation compared to a control group. About a fifth of the patients experienced complications so severe the devices had to be removed or revised.
A 2018 study found that SCSs have some of the worst safety records of medical devices tracked by the FDA. An FDA review of adverse events involving stimulators found that nearly a third were reports of poor pain relief. The review also identified nearly 500 deaths linked to the devices, along with nearly 78,000 injuries and 30,000 malfunctions.
SCS’s are no longer limited to patients with intractable back and neck pain. Last year the FDA expanded the use of stimulators to include lower limb pain from diabetic neuropathy. Stimulators are also being used on patients with Complex Regional Pain Syndrome (CRPS).
