SAN DIEGO, CA–(Marketwired – Jun 13, 2016) – An interim analysis of registry data evaluating therapeutic response to neurostimulation from a device for treating cluster headaches demonstrates the effectiveness of the therapy and was discussed during the poster sessions of the 58th Annual Scientific Meeting of the American Headache Society on Friday, June 10 in San Diego.
Cluster headache (CH) is a disabling neurological condition characterized by intense stabbing pain, often accompanied by swelling, tears, and nasal congestion. The pain caused by cluster headaches is recognized as among the most severe pain documented.1 The Pulsante® SPG Microstimulator System (ATI™ Neurostimulation System) was developed to treat patients with cluster headache by stimulating a nerve bundle behind the nose known as the sphenopalatine ganglion (SPG).
An interim analysis of post-market registry study (Pathway R-1) was conducted at 12 months following device insertion in CH patients to evaluate safety and long-term effectiveness of SPG stimulation. The Pathway R-1 analysis found that 68% (58/85) of patients were therapeutic responders, meaning they experienced either a reduction in attack frequency of at least 50% (frequency responders), effective therapy in at least 50% of the attacks that were treated (acute responders), or both. Effective therapy was defined as relief from very severe, severe or moderate pain down to mild pain, or freedom from very severe, severe, moderate or mild pain, all without the use of acute pain medications.
“We were encouraged by the findings of this open-label registry study because it reaffirmed the effectiveness of SPG stimulation for cluster headache patients, producing outcomes in the population that are consistent with the original outcomes in the randomized-controlled study,” said Rigmor Jensen of the Danish Headache Centre, University of Copenhagen, Glostrup, Denmark.
The study also found that attack frequency was reduced by 44% in the population (p < 0.0001), with frequency responders experiencing an 88% reduction. Acute effective therapy was achieved in 39% of attacks treated in the population, with acute responders achieving effective therapy in 86% of attacks.
In addition to changes in attack frequency and the percent of attacks achieving effective therapy, changes in the use of acute medications was evaluated. The population had a 52% reduction of acute medication (p < 0.0001).
The occurrence of side-effects in this population was not different from previously published data, which typically included sensory disturbances, post-operative pain, and swelling. These symptoms were generally considered mild to moderate and resolved within 2-3 months.2,3
The SPG neurostimulation therapy achieved CE Mark in Europe in 2012 and is currently under a clinical study sponsored by Autonomic Technologies, Inc. (Redwood City, CA) to evaluate its safety and effectiveness in the US for the treatment of chronic cluster headache.
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.
1 Fischera M et al. The incidence and prevalence of cluster headache: a meta-analysis of population-based studies. Cephalalgia. 2008 Jun;28(6):614-8 http://www.ncbi.nlm.nih.gov/pubmed/18422717
2 Jurgens TP, Barloese M, May A, et al. Long-term effectiveness of sphenopalatine ganglion stimulation for cluster headache. Cephalalgia 2016;(in press).
3 Assaf AT, Hillerup S, Rostgaard J, et al. Technical and surgical aspects of the sphenopalatine ganglion (SPG) microstimulator insertion procedure. Int J Oral Maxillofac Surg 2016;45:245-254.