Unity HA Awarded Breakthrough Device Designation for Implantable Neurostimulation Technology to Treat Cluster Headache Pain

EFFINGHAM, Ill., May 25, 2021 /PRNewswire/ --A Unity HA announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the PulsanteA® SPG Microstimulator System for the treatment of acute pain associated with chronic cluster headaches.A  "FDA's recognition of Unity HA's technology to substantially impact chronic cluster headaches is a significant milestone. The Pulsante SPG Microstimulator has treated over 700 patients in the US and EU," says Dr. Peter Bonutti, Unity HA's president.A  "Recently the results of a clinical trial were published in The Lancet journal1. This breakthrough designation brings us closer to a potential long-term treatment option for patients with cluster headaches."A  The Breakthrough Device Program was established by the FDA to provide patients and healthcare providers with timely access to transformative medical devices. About the PulsanteA® SPG Microstimulator System
The MRI compatible PulsanteA® Microstimulator System offers on-demand stimulation of the sphenopalatine ganglion (SPG), 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.
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