FDA Clears Peripheral Nerve Stimulators for Acute and Chronic Pain

The US Food and Drug Administration (FDA) has cleared 2 neurostimulation devices used to treat chronic and acute pain. The SPRINT endura (single lead) and extensa (dual lead) Peripheral Nerve Stimulation (PNS) Systems are indicated for the treatment of pain in the back and extremities for up to 60 days.

“Our SPRINT PNS platform is designed to deliver the least invasive and most user-friendly PNS therapy experience for physicians and their patients,” Maria Bennett, Founder, President and CEO of SPR Therapeutics, which received the FDA clearance for these devices, said in a statement.

The SPRINT endura and extensa are cleared for both chronic and acute pain including post-operative pain and post-traumatic pain. The PNS system leads are placed by a physician during an outpatient procedure that does not require surgery, incisions, tissue destruction or anesthesia.

“With the ease of use and dual lead capabilities we’ve built into the SPRINT System we look forward to advancing the early use of neurostimulation as a non-opioid alternative for more patients while we continue to generate data that demonstrate significant and sustained pain relief following our 60-day therapy,” continued Bennett.

Given the ongoing opioid epidemic, there have been developments in both drugs and devices as non-opioid alternatives for treating pain.

“The SPRINT PNS system provides a non-opioid therapy alternative that we have used successfully with many of our pain patients,” said interventional pain management physician Chris Gilmore, MD, of Carolinas Pain Institute in Winston-Salem, NC.

The FDA decision was based in part on data from several clinical trials of the SPRINT Peripheral Nerve Stimulation Systems. In one study of the SPRINT system for treating chronic pain, ≥50% reductions in pain or pain interference were reported among two-thirds of subjects after 8 weeks of treatment.

Of the 5 patients who have completed the full 12 months of treatment for the study, 80% (n = 4) have reported enduring and significant pain reduction (≥50%).

“In my experience, most patients prefer a non-permanent, non-destructive and non-surgical option for pain management when possible,” added Gilmore. “The minimally invasive nature of the SPRINT System allows us to introduce peripheral nerve stimulation therapy early in the care continuum, including its use in well-selected patients with back pain.”