FDA Clears Peripheral Nerve Stimulator for Pain Management

Megan Brooks

Disclosures

August 16, 2018

The US Food and Drug Administration (FDA) has cleared SPR Therapeutics' SPRINT endura (single lead) and extensa (dual lead) peripheral nerve stimulation systems pain management, the company has announced.

The SPRINT system is the only percutaneous peripheral nerve stimulation (PNS) system cleared by the FDA and indicated for up to 60 days in the back and/or extremities for both chronic and acute pain and is the only dual lead capable PNS platform, the company said in a news release.   

The SPRINT PNS platform allows physicians to implant two leads connected to a single wearable pulse generator during an outpatient procedure. Rechargeable batteries allow continuous stimulation delivery and a Bluetooth-enabled controller allow for patient-specific customization, the company said.

The SPRINT PNS reduced pain and improved quality of life in multiple clinical trials. Preliminary results from a federally funded multicenter study of SPRINT for the treatment of chronic postamputation pain showed significant reductions in pain or pain interference (≥50%) in two thirds of patients following the 8-week treatment period. Enduring and significant pain relief was reported by four of five patients (80%) who have completed the entire 12-month study.

"Our SPRINT PNS platform is designed to deliver the least invasive and most user-friendly PNS therapy experience for physicians and their patients. 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," said Maria Bennett, founder, president and CEO of SPR Therapeutics, said in the release.

"The SPRINT PNS system provides a non-opioid therapy alternative that we have used successfully with many of our pain patients," added Chris Gilmore, MD, from Carolinas Pain Institute in Winston-Salem, North Carolina.

"In my experience, most patients prefer a non-permanent, non-destructive and non-surgical option for pain management when possible. 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," said Gilmore.

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