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June 27, 2017

The Ischemic Stroke System (ISS)* is based on an implantable electrode and designed to deliver electrical stimulation to the Spheno-Palatine Ganglion (SPG). Upon activation (using an external system temporarily attached to the patient's cheek), the system augments cerebral blood flow (CBF). Treatment can be either acute (over a short period of time, hours or days) or chronic (over an extended period, months to years). In addition, the stimulation regimen selected determines the biological effect: a mild stimulation profile leads to gentle augmentation of cerebral perfusion aiding in the management of ischemic stroke or dementia, while a different, more intense regimen enhances the bioavailability of drugs in the CNS by increasing the permeability of the Blood Brain Barrier (BBB).

The ISS is an investigational device currently undergoing clinical studies to determine its safety and effectiveness in patients with acute ischemic stroke. It is implanted in a bed side, minimally invasive procedure under local anesthesia.

The ISS is comprised of the following components: 

- A miniature implantable neurostimulator (INS) - an electrode-equipped implant that is placed adjacent to the SPG in the palatine canal. The INS is inserted into the palatine canal through the greater palatine foramen near the third molar, making the implantation a simple procedure. The INS is MRI compatible thus permits any scan modality to be used as needed.

- A driver worn by the patient on an armband during stimulation sessions.

- A transmitter placed on the patient's cheek, attached by a sticker, to transmit electrical energy from the driver to the implant.

- A controller that allows the caregiver to set treatment parameters and view the system logs.

To see how the ISS is used to treat stroke victims click here.

* Caution: Investigational device. Limited by Federal (or US) law to investigational use.
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