Device Review: Pulsante™ Sphenopalatine Ganglion Microstimulator

Abstract

Cluster headache (CH) is a primary headache disorder. The use of neuromodulation in treatment of CH is well documented. The sphenopalatine ganglion (SPG) has long been a target for management of CH. Intervention at the level of the SPG can interrupt the trigemino-autonomic reflex, which mediates CH pain. The Pulsante system is the only device on the market created for SPG stimulation. The Pulsante device consists of the device body, a lead with six stimulating electrodes placed in the pterygopalatine fossa, and a fixation plate to allow anchoring of the device to the maxilla. Stimulation is administered via a patient-controlled handheld remote control held over the cheek. SPG stimulation is an important treatment option for CH patients.

Keywords::

• cluster headache
• neuromodulation
• Pulsante microstimulator
• refractory cluster headache
• sphenopalatine ganglion stimulation

Financial & competing interests disclosure

No direct funding was used for this project. The authors are employees of the Duke University Health System. L Roy serves as a consultant for Medtronic, Inc. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.