FDA Clears SPR Therapeutics’ Non-opioid SPRINT endura and extensa Peripheral Nerve Stimulation Systems for Pain Management
CLEVELAND, Aug. 16, 2018 (GLOBE NEWSWIRE) — SPR Therapeutics, Inc., a leader in neurostimulation technology for pain, today announced that the U.S. 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 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.
SPR Therapeutics’ SPRINT Peripheral Nerve Stimulation (PNS) System leads are placed by a physician during an outpatient procedure without surgery, incisions, tissue destruction or anesthesia offering a minimally invasive and non-opioid 60-day therapy. SPRINT has demonstrated significant and sustained pain relief across multiple studies. For additional information regarding safety and efficacy visit www.sprtherapeutics.com.
“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 customization 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 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. 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 from August 16-19 and at the Military Health System Research Symposium from August 20-23.
SPR Therapeutics’ SPRINT extensa™ Peripheral Nerve Stimulation (PNS) System is the only FDA-cleared percutaneous PNS System. SPRINT PNS is indicated for both chronic and acute pain and is the industry’s only dual lead capable PNS platform. SPRINT, a minimally invasive and non-opioid 60-day therapy, has demonstrated significant and sustained pain relief across multiple studies. For additional information regarding safety and efficacy visit www.sprtherapeutics.com.
About SPRINT PNS System
The SPRINT Peripheral Nerve Stimulation (PNS) System is the only percutaneous PNS device that is FDA-cleared for both chronic and acute pain, including post-operative and post-traumatic pain. The SPRINT PNS System leads are placed by a physician during an outpatient procedure without surgery, incisions, tissue destruction or anesthesia offering a minimally invasive and non-opioid 60-day therapy. SPRINT has demonstrated significant and sustained pain relief across multiple studies. For additional information regarding safety and efficacy visit www.sprtherapeutics.com.
About SPR Therapeutics
SPR Therapeutics, Inc. is a privately-held neurostimulation company headquartered in Cleveland, Ohio. The company’s SPRINT technology is commercially available and provides peripheral nerve stimulation, a non-opioid therapy, for the relief of chronic and acute pain. Multiple clinical trials have been completed and additional clinical trials are underway in the treatment of low back pain and peri-operative pain. More information can be found at: www.sprtherapeutics.com.
SPR Contact:
Mark Stultz
Senior Vice President
[email protected]
612-770-0390
Media Contact:
Helen Shik
Shik Communications
[email protected]
617-510-4373
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