Cyberonics announced new results from two multi-site clinical studies of the AspireSR generator, E-36 and E-37, at the American Epilepsy Society Annual Meeting (AES; 5–9 December, Seattle, USA).
Investigators presented results from the European E-36 study and the US E-37 study, which assessed the acute impact of the AspireSR generator on seizure duration and termination, as well as the long-term evaluation of safety, clinical benefit of the automatic stimulation feature, and quality of life. Assessments of seizure severity and quality of life were made using validated scales scored by patients, and physicians.
The acute impact of the AspireSR generator on seizure duration and termination was evaluated during the Epilepsy Monitoring Unit stay period experienced by all patients in both studies. Seizure activity was recorded using concurrent video-electroencephalography (EEG) and electrocardiogram (ECG) monitoring. Patients in both studies experienced termination of seizures as well as reduced seizure duration during automatic stimulation compared to historical controls.
During three- and six-month follow-up, patients in both studies experienced clinically significant reduction in several key components of seizure activity compared to baseline, including overall seizure severity, movements that could result in harm, and various aspects of post-ictal recovery.
“These clinical results show that the AspireSR vagus nerve stimulation (VNS) therapy system is safe and effective for detecting and reducing the burden of seizures in patients with drug-resistant epilepsy,” says Paul A J M Boon, professor and chairman of the Department of Neurology and director, Institute for Neuroscience, Ghent University Hospital. “The AspireSR generator shows a similar clinical benefit to the manual magnet-activated stimulation provided by the existing VNS therapy systems, but with added convenience to both the patient and caregiver.”
“More than 60% of patients receiving VNS therapy report benefits from manual magnet activation, yet not all patients can use this feature during a seizure as the result of the disabling effects of the seizure, cognitive impairment, seizures that occur during sleep, or seizures that occur without an aura,” adds Robert Fisher, director of the Stanford Epilepsy Center, Palo Alto, USA. “The AspireSR generator delivers programmed VNS therapy with the addition of automatic stimulation based upon the increased heart rate that accompanies many seizures. This feature can provide the acute stimulation benefit to more patients with drug-resistant epilepsy.”
The AspireSR generator is investigational in the USA and not approved for commercial use. The device has attained the CE mark and is available in an increasing number of European countries.
