FDA Clears SPR Therapeutics’ Peripheral Nerve Stimulation Systems for Pain Management

PNS gets FDA clearance

SPR Therapeutics, Inc., a Cleveland, Ohio-based developer of neurostimulation technology for pain, announced that it has received FDA clearance for 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 is the industry’s only dual lead capable PNS platform. Additionally, the updated platform now supports rechargeable batteries and a Bluetooth-enabled controller for patient use.

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“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.

SPR Therapeutics’ percutaneous electrical nerve stimulator is a non-narcotic alternative for chronic and acute pain relief indicated for up to 60 days of use in the back or extremities, reports MobiHealthNews. The treatment does not require any type of permanent implant, invasive surgery, tissue destruction, or opioid prescription. A wearable stimulator is connected to a 0.2 mm wire placed through the skin. The system activates target nerve fibers to relieve pain.

“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,” said interventional pain management physician Chris Gilmore, MD, of Carolinas Pain Institute in Winston-Salem, NC.

PNS gets FDA clearance
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.

The new benefits offered by the SPRINT PNS platform are:

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

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Preliminary results from a multicenter study showed significant reductions in pain or pain interference were reported among two-thirds of subjects following the 8-week treatment period. Enduring and significant pain relief was reported by four of the five patients (80 percent) who have completed the entire 12-month study, according to the company. The majority of these patients were using the dual lead version of the company’s offering.