Indications for use
The SPRINT Peripheral Nerve Stimulation (PNS) System is indicated for up to 60 days for:
- Symptomatic relief of chronic, intractable pain, post-surgical and post-traumatic acute pain;
- Symptomatic relief of post-traumatic pain;
- Symptomatic relief of post-operative pain.
The Sprint PNS System is not intended to be placed in the region innervated by the cranial and facial nerves.
Use of the SPRINT® PNS System is contraindicated for:
- Lead placement over the heart or across the thoracic volume.
- Lead placement in the front or side of the neck.
- Lead placement on the top of the head.
- Patients who have a Deep Brain Stimulation (DBS) system.
- Patients who have an implanted active cardiac implant (e.g. pacemaker or defibrillator).
- Patients who have any other implantable neuro-stimulator whose stimulus current pathway may overlap with that of the SPRINT System.
- Patients who require Magnetic Resonance Imaging (MRI). The SPRINT MicroLead™ and other SPRINT components must be removed from the body before an MRI.
- Patients who have epilepsy, if the leads are intended to be placed in the head or neck.
- Patients who have a tape or adhesive allergy.
Adverse events (Side Effects)
The most common device-related adverse event reported in clinical studies was skin irritation (which may include inflammation, mild blistering, and/or erythema). Other less-reported events included itching at the electrode exit site, granuloma, pain after electrode placement, and infection. The majority of the device-related adverse events in sponsored clinical studies were resolved with little to no intervention within a few days, and none were classified as serious.
Similar adverse events have been reported during commercial use. Infections have been reported for about 1-2% of patients. Serious adverse events have been rare.
MRI safety information
NOTE: Patients that received a SPRINT System prior to September 1st, 2022, should contact SPR Therapeutics to obtain specific MRI safety information. (Phone: 844-378-9108)
All other SPRINT patients should use the information listed below:
Full MRI safety information is available here: