(Sprint PNS System. Image courtesy of SPR Therapeutics.)
The U.S. Food and Drug Administration has given the green light to a new pain relief-system made by SPR Therapeutics, a Cleveland-based company that specializes in neurostimulation devices. The product is known as the SPRINT PNS System, and it comes in two types: endura (a single-lead system) and extensa (double-lead).
The SPRINT PNS System uses what’s called a percutaneous technique. Percutaneous means “through the skin” — in other words, therapy is applied by means of small leads (thread-like wires) inserted under the skin. In the SPRINT PNS System, the physician places the leads during an outpatient procedure without surgery, incisions, anesthesia, or permanent implants (PNS stands for “peripheral nerve stimulation”). The leads are connected to a wearable pulse generator that has rechargeable batteries. The generator provides continuous stimulation and a Bluetooth controller lets the patients customize the therapy as needed.
According to the manufacturer, SPRINT is the only percutaneous PNS system cleared by the FDA and indicated for up to 60 days in the back or extremities, or both, for both chronic and acute pain. It’s also the only dual-lead capable PNS platform. A clinical trial showed that after eight weeks of use, two-thirds of patients experienced “significant” pain reductions. Of the patients who completed the full year-long study, four out of five had “enduring and significant” relief.
One of the more newsworthy aspects of the SPRINT system is that it can provide pain relief without the use of opioid medications — a welcome benefit now that the overuse of opioids is so much in the news.