SPR Therapeutics announced that the Food and Drug Administration (FDA) has granted clearance for SPRINT endura (single lead) and extensa (dual lead) Peripheral Nerve Stimulation (PNS) Systems.
The percutaneous SPRINT PNS System is indicated for use up to 60 days in the back and/or extremities for chronic and acute pain, including post-operative and post-traumatic pain. The System leads are placed by a physician during an outpatient procedure; no surgery, incisions, tissue destruction or anesthesia are required.
Several clinical trials have demonstrated the SPRINT PNS System to be effective in reducing pain and improving quality of life. Early results from a multicenter study that evaluated SPRINT for chronic post-amputation pain showed significant reductions in pain or pain interference (≥50%) among two-thirds of patients after 8 weeks of treatment. In addition, enduring and significant pain relief (≥50%) was reported in 80% of patients after 12 months of treatment.
The platform now features dual lead capability which allows physicians to implant 2 lead connected to a single wearable pulse generator. Also, rechargeable batteries provide continuous stimulation while the Bluetooth-enabled controller allows patient-specific customization.
For more information visit SPRtherapeutics.com.