FDA Clearance for Low Risk, Minimally Invasive, Completely Reversible Peripheral Nerve Stimulation Device System

In a recent press release SPR® Therapeutics announced that it has received clearance from the US Food and Drug Administration to commercialize its SPRINTTM Peripheral Nerve Stimulation (PNS) System. Described by the manufacturer as the first and only PNS approach that is minimally invasive and completely reversible, the SPRINT system is offered as a therapeutic option for postoperative and posttraumatic pain, both chronic and acute. SPR Therapeutics founder, president and CEO Maria Bennett, asserted that SPRINT “…will be a game changer in the world of pain management” and added that “The FDA’s clearance comes at a critical time when physicians, patients, and the US healthcare system are seeking therapies to manage pain while reducing opioid use.”

The SPRINT PNS system is comprised a coiled lead that is placed percutaneously and a matchbox-sized wearable electrical stimulator. Because the lead can be located up to 2 to 3 cm from the targeted nerve, the placement procedure is simplified for clinicians and can be accomplished on an outpatient basis without surgery or anesthesia. The system further provides the physician with the ability to preferentially stimulate specific nerve fibers for optimal effect. The device is designed to be withdrawn without surgery following a 30 day treatment period. A clinical trial referenced by the manufacturer reported a 72% reduction in average pain associated with use of the SPRINT system.

Read more about peripheral nerve stimulation, here.

The press announcement, with links to further information about the product, may be read here.



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