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
The MRI compatible Pulsante® 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.
About Cluster Headache
Cluster headache is a disabling chronic neurological condition characterized by intense stabbing pain in one eye, often accompanied by swelling, tears and nasal congestion. The pain inflicted is among the most severe known. Sufferers can have multiple attacks per day, each lasting minutes to hours. Approximately 1 in 1,000 people suffer from cluster headaches.
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
Unity HA is a medical device company focused on the development and commercialization of innovative therapies for the treatment of cranial autonomic disorders, particularly severe headaches. The company acquired the assets of Autonomic Technologies, Inc. (ATI) and continues to advance cost-effective technologies for the prevention and treatment of cluster headaches. Unity HA, a subsidiary of Bonutti Research, Inc., is a medical device incubator founded in 1989 with over 400 patents and 700 licenses.
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.
SOURCE Unity HA