Posted by Michael Wonder on 26 May 2021
Unity HA awarded breakthrough device designation for implantable neurostimulation technology to treat cluster headache pain
25 May 2021 - Unity HA announced today that the U.S. FDA has granted breakthrough device designation to the Pulsante SPG Microstimulator System for the treatment of acute pain associated with chronic cluster headaches.
The MRI compatible Pulsante Microstimulator System offers on-demand stimulation of the sphenopalatine ganglion, which plays a critical role in headaches with autonomic features, such as cluster headache. The battery-free implant allows patients to deliver as-needed stimulation to relieve the attack, using an external controller.
