FDA clears SPR Therapeutics’ peripheral nerve stimulation system for head, neck, torso
The FDA cleared SPR Therapeutics’ Sprint Peripheral Nerve Stimulation system, which had been approved for the back and extremities, for use on the head, neck and front of the torso, according to a press release.
“This is a tremendous milestone for SPR and the Sprint System,” Maria Bennett, CEO, president and founder of SPR Therapeutics, said in the release. “We look forward to the opportunity to bring effective pain relief to even more patients seeking alternatives to other more invasive treatment options.”
The Peripheral Nerve Stimulation (PNS) system has been used in nearly 7,000 patients to manage their pain without tissue destruction or a permanent implant, and clearance was based on real world safety data from more than 5,500 patients. With the new indications, millions of patients with certain head, neck and torso pain can use the system, according to the release.
“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,” Matthew Pingree, MD, of Mayo Clinic Hospital, Saint Marys Campus in Rochester, Minnesota, said in the release.