Peripheral nerve stimulation systems receive FDA clearance

17th August 2018

Enaie Azambuja

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SPR Therapeutics has announced that the FDA has cleared its SPRINT endura (single lead) and extensa (dual lead) Peripheral Nerve Stimulation (PNS) Systems. The SPRINT System is the only percutaneous 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 industry’s only dual lead capable PNS platform.

“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.

“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.

“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.”

This SPRINT PNS platform offers several new benefits:

Dual lead capability allows physicians to implant two leads connected to a single wearable pulse generator
Rechargeable batteries allow continuous stimulation delivery
Bluetooth enabled controller fosters patient-specific customisation and ease of use

Multiple clinical trials evaluating SPRINT have demonstrated its ability to reduce pain and improve quality of life. Preliminary results from a Federally-funded multicenter study of SPRINT for the treatment of chronic post-amputation pain demonstrate that significant reductions in pain or pain interference (≥50 percent) were reported among two-thirds of subjects following the 8-week treatment period.

Enduring and significant pain relief (≥50%) was reported by four of the five patients (80 percent) who have completed the entire 12-month study according to data being presented at the Napa Pain Conference. The vast majority of these subjects were implanted with dual (femoral and sciatic) leads.

To learn more about SPRINT, visit SPR Therapeutics at the Napa Pain Conference and at the Military Health System Research Symposium.