FDA Gives Nod To First Percutaneous Peripheral Nerve Stimulation Device

On Wednesday, Boston Scientific announced that it’s acquiring a company that makes radio-frequency ablation devices, underscoring the need to offer medtech alternatives to treating chronic pain, which is overwhelmingly addressed by drugs.

Another company that is offering up a device solution to the current opioid crisis is SPR Therapeutics. The Cleveland company announced Thursday that the Food and Drug Administration has cleared its Sprint peripheral nerve stimulation system (PNS) to relieve patients of chronic and acute pain, including post­operative and post­-traumatic pain.

SPR bills the device as the first and only percutaneous, minimally invasive and completely reversible PNS system compared with others that require the pulse generator and leads to be implanted.

Implantable or external, such devices fall under the broad umbrella of neuromodulation by which patients receive mild electric pulses or stimulation on certain nerve tissues intended to disrupt pain signals from the brain.

“The FDA’s clearance comes at a critical time when physicians, patients and the U.S. healthcare system are seeking therapies to manage pain while reducing
opioid use,” said Maria Bennett, SPR Therapeutics founder, president and CEO, in a news release. “SPR has developed a drug ­free treatment for relieving chronic and acute pain.”

Patients wear the company’s external stimulator that send the electric pulses through a lead placed through the skin in the target area. Placing the lead and getting the wearable stimulator connected to it can be done in an outpatient procedure requiring no surgery. After the 30-day period, the lead and wearable stimulator can be removed.

“Clinical trials demonstrate that pain relief is provided during therapy and may be sustained following the therapy period,” Bennett said via email, but didn’t specify the duration of the pain relief following that 30-day therapy period.

One small study funded by the National Institutes of Health showed that the Sprint system was able to achieve significant pain reduction in patients who had undergone amputation.

Read the full story at Med City News.