The FDA granted 510(k) clearance to expanded labeling for the SPRINT PNS (peripheral nerve stimulation) system (SPR Therapeutics). The new labeling increases the intended patient population for treatment with the device, and includes new advances to the system’s lead securement mechanism.
The patient population for the SPRINT PNS system has expanded to include those ages 18 years and older (previously 21 years and up). The SPRINT PNS system is indicated for up to 60 days for symptomatic