SPR Therapeutics has announced in a press release that the US Food and Drug Administration (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 US 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.
“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, USA. “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 multicentre study of SPRINT for the treatment of chronic post-amputation pain demonstrate that significant reductions in pain or pain interference (≥50%) 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%) who have completed the entire 12-month study according to data being presented at the Napa Pain Conference, August 16-19, 2018. The vast majority of these subjects were implanted with dual (femoral and sciatic) leads.