FDA Clears SPR Therapeutics’ Non-Opioid Neurostimulation Pain Therapies

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The U.S. Food and Drug Administration (FDA) cleared Cleveland-based SPR Therapeutics SPRINT endura (single lead) and extensa (dual lead) Peripheral Nerve Stimulation (PNS) Systems for controlling pain.

The SPRINT System is the only percutaneous PNS System cleared by the agency and is indicated for up to 60 days in the back and/or extremities for chronic and acute pain. It is the only dual lead capable PNS platform in the industry.

Peripheral nerve stimulation (PNS) delivers rapid electrical pulses, which are described as feeling like mild tingling. Common usage is for certain complex regional pain syndrome, peripheral nerve injuries, back pain, occipital nerve stimulation for the treatment of migraine headaches, and others.

The system uses a “MicroLead” delivered by way of a 20-gauge introducer. One end is connected to a wearable controller device. The MicroLead has a barbed anchor that holds it in place, but a highly flexible coil of the lead allows the patient freedom of movement.

Physicians are able to implant two leads connected to a single wearable pulse generator during an outpatient procedure. It has rechargeable batteries and a Bluetooth-enabled controller.

The idea is that it can be used to treat pain without pain medications, which hopefully will prevent the addiction so common with opioids. Preliminary results from a SPRINT clinical trial for the treatment of chronic postamputation pain has early data showing significant decreases in pain or pain interference in two-thirds of patients after the 8-week treatment period. Longer-term pain relief was seen in four out of five patients who completed the entire 12- month trial.

“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, SPR Therapeutics’ founder, president and chief executive officer, in a 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 device received a 510(k) approval. It is classified by the FDA as a percutaneous electrical nerve stimulator (PENS), somewhat different than what the PNS name would suggest. The FDA classifies PNS as intended for long-term implantation within the body, while this system is designed for shorter outpatient procedures.

In September 2018, SPR Therapeutics closed on a $25 million Series C financing led by Frontcourt Ventures. It has also received a total of $9 million in contracts from the U.S. Department of Defense. The primary competition in the marketplace is NeuroMetrix’s Quell.

“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, North Carolina, in a statement. “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.”

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