How the Pulsante® SPG Microstimulator System Works
Neurostimulation is a well-established pain treatment used throughout the body to treat chronic pain.1 Using the same principles, the novel Pulsante SPG Microstimulator is designed to reach the sphenopalatine ganglion (SPG) nerve bundle. The SPG nerve bundle sits behind your cheek. It acts as the body’s “fuse box” along the pain pathway for cluster headaches.
Inserted near the SPG nerve bundle, the Pulsante SPG Microstimulator is designed to direct mild electrical pulses to interfere with pain messages before reaching the brain.
Users begin stimulation by turning on a remote controller and holding it on the cheek over the inserted device. When finished, the remote controller is simply pulled away from your cheek, turning off stimulation. Clinical studies report that patients experience pain relief from most attacks within 15 minutes.2
Designed for a Simple Procedure
The Pulsante System is designed to be inserted through a minimally invasive procedure that leaves no visible scars.
During the procedure, the Pulsante SPG Microstimulator (about the size of an almond) is inserted through a small incision in the mouth, in the upper gum above the back molars. Clinical studies show that the procedure is comparable to oral cavity interventions, such as a wisdom tooth removal.3,4
A natural, boney pathway above the second molar known as the pterygopalatine fossa allows the microstimulator to reach the SPG nerve bundle. To help guide the implant, the surgeon may use fluoroscopic guidance with live imaging to facilitate proper placement of the implant. The minimally invasive procedure generally takes about 60 to 90 minutes for trained surgeons to perform.
- International Neuromodulation Society. Neuromodulation: An Emerging Field. (2016 Dec. 12) Retrieved from http://www.neuromodulation.com/medical-therapy-overview
- Schoenen, et al. Stimulation of the sphenopalatine ganglion (SPG) for cluster headache treatment. Pathway CH-1: A randomized, sham-controlled study. Cephalalgia, 2013; 33:816-30
- Tung, et al. Surgical complications of the Le Fort I osteotomy – a retrospective review of 146 cases. Changgeng Yi Xuan Zag Zhao 1995; 18:102–107.
- Al-Din, et al. Sensory nerve disturbance following Le Fort I osteotomy. In J Oral Maxillofac Surd 1996; 25: 13–19.