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FDA gives nod to first percutaneous peripheral nerve stimulation device

Northeast Ohio

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.

That study noted that the invasive nature of PNS coupled with the challenge in placing leads that are required to be less than 2 mm from the targeted nerve means that the therapy, which could reduce pain, is rarely used. By contrast, the Sprint lead can be placed as far away from the nerve as 3 cm.

While all PNS devices are implanted in the U.S., according to Bennett, St. Jude Medical does have an external spinal cord stimulator that can be controlled by an iPod touch called the Invisible Trial System. But it is primarily meant to evaluate the value of spinal cord stimulation in order to decide whether the patient wants a permanent implant.

The market for pain management devices is growing with one report from BCC Research forecasting it to be worth $3.5 billion in 2020, up from $3.1 billion last year.

SPR Therapeutics was founded in January, 2010 as a portfolio company of NDI Medical, a hybrid venture capital and commercialization firm focusing exclusively on neurodevice technologies.

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