Two-Year Study Results Show the Pulsante® Microstimulator Provides Sustained, Longterm Relief for Cluster Headache Patients »
New hope for cluster headache sufferers
Redwood City, USA, May 19th, 2016 – A peer-reviewed paper* in the International Headache Society journal Cephalagia reported that cluster headache patients treated with the Pulsante® Microstimulator achieved effective pain relief for 24 months. Over 60% of patients enrolled in a follow-up of the original Pathway CH-1 study maintained their therapeutic response for two years.
A total of 5,956 attacks were evaluated across 33 chronic cluster headache patients in the open-label follow-up study. At two years, 45% of patients experienced acute effectiveness in ≥ 50% of attacks by using only the Pulsante® Microstimulator. Furthermore, 33% of patients experienced a ≥ 50% reduction in attack frequency versus baseline. A total of 61% of patients were acute and/or frequency responders in the long-term study.
The Pulsante® Microstimulator is the first electroceutical device with documented long-term effectiveness for the treatment of cluster headache. The system stimulates the sphenopalatine ganglion (SPG), which plays a critical role in cluster headache pathophysiology. The device is inserted through the gum using a minimally invasive technique that leaves no visible scars. The targeted therapy provides both pain relief from acute cluster headaches and/or a reduction in cluster headache frequency, reducing cluster headache disability.
* Long-term effectiveness of sphenopalatine ganglion stimulation for cluster headache: Tim P Jürgens, Mads Barloese, Arne May, Jose Miguel Láinez, Jean Schoenen, Charly Gaul, Amy M Goodman, Anthony Caparso, and Rigmor Højland Jensen, Cephalalgia, 2016. (http://www.ati-spg.com/europe/en/atineurostimulation-system/publications/)
About Autonomic Technologies Autonomic Technologies, Inc.
(ATI®) is a medical device company headquartered in the San Francisco Bay Area with offices in Germany and Switzerland, focused on the development and commercialization of innovative therapies for the treatment of autonomic disorders, particularly severe headache. The company’s initial product, the Pulsante® Microstimulator, is CE marked in Europe for the treatment of cluster headache. The device (also known as Autonomic Technologies, Inc. (ATI®) Neurostimulation System) is under an IDE study in the US for the treatment of chronic cluster headache. ATI is backed by world-class European and US investors including Edmond de Rothschild Investment Partners, Forbion Capital Partners, HBM Healthcare Investments, Kleiner Perkins Caufield and Byers, InterWest Partners, Aberdare Ventures, Novartis Venture Funds, Capital Royalty Group and Cleveland Clinic. For more information, please visit: www.pulsante.eu or www.ati-spg.com. 0119007.A