SPR Therapeutics Announces FDA Clearance of an Expanded Indication for the SPRINT® PNS System
SPR Therapeutics® has obtained clearance from the U.S. Food and Drug Administration (FDA) of a broader indication for use for its SPRINT Peripheral Nerve Stimulation (PNS) System. Prior clearance limited use of the SPRINT PNS System to the back and extremities, but the new indication allows the device to be used in areas of the head, neck, and the front of the torso. The clearance was based on real world safety data collected from over 5,500 patients using the SPRINT PNS System commercially, both on-label and off-label.
Even without this expanded indication the pace of SPRINT System growth has more than doubled in the past year, having been used to treat nearly 7,000 patients to date, many of whom are seeking a pain management solution that does not require tissue destruction or a permanent implant. The expanded indication allows access to the many millions of patients with certain types of head, neck and torso pain.
“I have had great success in utilizing the SPRINT PNS System for many of my patients and I’m pleased that the expanded indication allows me to now treat these areas of high interest in an on-label manner while also allowing many more patients to receive prior authorization support from the SPRcare® market access team,” said Dr. Matthew Pingree of Rochester, MN.
“This is a tremendous milestone for SPR and the SPRINT System,” said Maria Bennett, CEO, President and Founder of SPR Therapeutics. “We look forward to the opportunity to bring effective pain relief to even more patients seeking alternatives to other more invasive treatment options.”
Learn more about SPR Therapeutics and the SPRINT PNS System here