The FDA has approved SPR Therapeutics’ (Cleveland) Sprint endura (single lead) and extensa (dual lead) peripheral nerve stimulation (PNS) systems.
The minimally invasive Sprint system is the only FDA-approved percutaneous PNS system that is 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, according to the company.
“Our Sprint PNS platform is designed to deliver the least invasive and most user-friendly PNS therapy experience for physicians and their patients,” said Maria Bennett, founder, president & CEO of SPR Therapeutics, in a prepared statement. “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.”
The Sprint PNS platform’s dual lead capability allows physicians to implant two leads connected to a single wearable pulse generator. Implantation occurs as a minimally invasive outpatient procedure. The system uses rechargeable batteries and has a Bluetooth-enabled controller.
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 eight-week treatment period. Enduring and significant pain relief (≥50 percent) 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, August 16-19, 2018. Most of these subjects were implanted with dual (femoral and sciatic) leads.
“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 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.”
