The expanded FDA approval enhances the intended patient population that can be treated using SPRINT PNS System to include patients aged 18 and above, along with new advances to its lead securement mechanism
SPR Therapeutics SPRINT PNS System. (Credit: SPR Therapeutics)
SPR Therapeutics, a medical device company focused on treating pain, has obtained expanded approval from the US Food and Drug Administration (FDA) for its SPRINT Peripheral Nerve Stimulation (PNS) System.
The expanded FDA approval enhances the intended patient population that can be treated using SPRINT PNS System, along with new advances to its lead securement mechanism.
It expands the indication of SPRINT PNS to include patients aged 18 and above, from the previous indication for 21 years and above.
The expanded approval enables more patients to benefit from the unique peripheral nerve stimulation approach, said the medical device company.
SPR Therapeutics director of medical affairs Marc Huntoon said: “Our objective is to stay at the forefront of PNS innovation to reduce or eliminate pain, while minimising opioid treatments and the need for more destructive or invasive interventions.
“These labelling changes open the door to effectively reach younger patients that can benefit from our breakthrough treatment.
“We are a company driven by clinical research and devoted to improving the lives of people living with pain while anticipating the needs of our physician partners.”
The SPRINT PNS System is a 60-day treatment to recondition the central nervous system to provide significant and sustained relief from chronic pain.
The system eliminates a permanent implant, nerve destruction or the risk of addiction.
It has been approved for symptomatic relief of chronic, intractable pain, post-surgical and post-traumatic pain, along with postoperative pain.
The SPRINT PNS System is not intended to be placed in the region innervated by the cranial and facial nerves.
The updated indication recommends using leads placed in the back of the head and neck, to address pain experienced in those regions.
SPR Therapeutics said that SPRINT PNS is the only implantable PNS system that enables on-label stimulation of the occipital nerve to treat chronic pain.
In addition, the new lead securement component kit offers an improved method to secure the lead once it has been implanted and simplifies the device care during the treatment period.