Unity HA Awarded Breakthrough Device Designation for Implantable Neurostimulation Technology to Treat Cluster Headache Pain
EFFINGHAM, Ill., May 25, 2021 /PRNewswire/ -- Unity HA announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the Pulsante® SPG Microstimulator System for the treatment of acute pain associated with chronic cluster headaches.
"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.
"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."
The Breakthrough Device Program was established by the FDA to provide patients and healthcare providers with timely access to transformative medical devices.
About the Pulsante® SPG Microstimulator System
About Cluster Headache
There is no cure for the condition. Current symptom relief includes preventive and abortive drugs, injectable medications and inhaled oxygen. Some patients are not candidates for these medications, while others may experience no benefit from them.
About Unity HA
1. Goadsby, P. J., et.al. (2019). Safety and efficacy of sphenopalatine ganglion stimulation for chronic cluster headache: a double-blind, randomized controlled trial. The Lancet Neurology, 18(12), 1081–1090.
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SOURCE Unity HA