Cyberonics, Inc. has presented results from the E-36 clinical study of the AspireSR generator at the annual AES Meeting at the Walter E Washington Convention Centre in Washington, DC.
Paul Boon, senior full professor of Neurology and director of Ghent Institute for Neuroscience at Ghent University presented the results of the study entitled, "Vagus Nerve Stimulation Triggered by Cardiac-Based Seizure Detection, A Prospective Multi-centre Study," on December 7, 2013. The study (NCT01325623) was designed to evaluate the performance and safety of the AspireSR generator and its IntelliSense cardiac-based seizure detection feature.
Prof. Boon and clinical research colleagues at 13 other European centers implanted a total of 31 patients with the investigational AspireSR generator, which provides "normal mode" VNS Therapy augmented by seizure response stimulation. After the implant procedure and initial stimulation adjustment period, patients were admitted to an epilepsy monitoring unit for up to five days and monitored to identify seizures and collect heart-rate data.
The study met its primary endpoint in that the AspireSR generator, with IntelliSense cardiac-based seizure detection, detected more than 80 per cent of seizures accompanied by ictal tachycardia (heart-rate increase) at a range of programmable settings. The potential false detection rates were low. The detections occurred close, and in some cases prior, to seizure onset, which may improve the effectiveness of the therapy. In a clinical study evaluating 9,482 seizures, augmentation of VNS Therapy with manually-activated acute stimulation at seizure onset terminated 24 per cent of seizures and diminished the severity or duration of another 38 per cent of seizures.
The recently published evidence-based guideline update by the American Academy of Neurology on the use of VNS Therapy in epilepsy includes a recommendation that acute stimulation may be associated with seizure termination when used at the time of seizure auras. The safety profile for the AspireSR generator is consistent with currently available VNS Therapy systems.
"The E-36 study demonstrated the accuracy of the cardiac-based seizure detection algorithm for seizures with heart rate changes," said Prof. Boon. "Triggering stimulation when a seizure is detected should benefit patients with refractory epilepsy given the evidence that on-demand stimulation using the magnet can acutely interfere with seizure activity."
"The AspireSR product represents an important milestone in Cyberonics' ongoing commitment to provide technologically-advanced device-based solutions for people with epilepsy. We believe the addition of the proprietary IntelliSense seizure-response feature will continue to advance VNS Therapy as a foundational therapy for patients with refractory epilepsy," said Dan Moore, president and CEO of Cyberonics.
Cyberonics, Inc. is a medical technology company with core expertise in neuromodulation. The company developed and markets the VNS Therapy System, which is FDA-approved for the treatment of refractory epilepsy and treatment-resistant depression.