Pulsante™ System

Autonomic Technologies, Inc. (ATI) has developed the Pulsante™ SPG Microstimulator System to provide on-demand SPG stimulation therapy with the intention to relieve the acute debilitating pain of cluster headache. The Pulsante System is a minimally-invasive, rechargeable, multi-channel, peripheral nerve stimulation system. The System includes:

  1. The Insert: A microstimulator (smaller than an almond) with an integral lead designed to fit ranging facial anatomy. The insert has CE-marked MR Conditional labeling for whole-body MRI.
  2. The Remote Controller: A hand-held device with simple therapy controls that provides on-demand patient-controlled SPG therapy. Therapy settings are individualized and can be adjusted quickly by physicians using a programmer laptop.

Clinical data from the Pathway CH-1 Study on the safety and efficacy of the Pulsante System was published in Cephalalgia, a peer-reviewed journal.

The device is inserted through a small incision in the upper gum above the second molar and positioned at the sphenopalatine ganglion (SPG) nerve bundle. The SPG is located deep in the face on either side of the nose. The neurostimulator is placed on the side of the patient’s headache pain. The procedure leaves no visible scars.

patient using ATI Neurostimulation SystemThe patient controls his or her own stimulation treatment as needed by turning on the Remote Controller and placing it on the cheek over the inserted device. When the patient no longer desires stimulation, the Remote Controller is simply removed from the cheek, turning off stimulation therapy.

If SPG Stimulation Therapy and use of the Pulsante System is no longer needed, the device can be left in place or, if desired, can be removed under local anesthetic in an outpatient procedure.

Click here to learn more about clinical data that supports the Pulsante System.

Neurostimulator

Inserted Neurostimulator

Remote Controller

Handheld Remote Controller

First of its kind microstimulator specifically designed for cluster headache patients.

 
© 2012-2015 Autonomic Technologies, Inc. All Rights Reserved. Last updated: 08 January 2015
CE Marked Intended Use: The Pulsante™ SPG Microstimulator System (ATI Neurostimulation System) is CE marked in Europe and is intended to relieve the acute pain of cluster headache. In some patients the use of the System has been associated with a reduction in the number of cluster headaches.
In the United States please note: Caution–Investigational device; limited by US law to investigational use.