LivaNova (NSDQ:LIVN) said today it launched a new feasibility trial of its Microburst Vagus Nerve Stimulation therapy system exploring its safety and effectiveness in treating patients with drug-resistant epilepsy.
The London-based company said that Dr. Rebecca O’Dwyer of Chicago’s Rush University Medical Center has enrolled the first patient in the trial, which aims to enroll a total of 40 patients at 15 US sites.
“At the Rush Epilepsy Center, we are very dedicated to research and advancing the field of epilepsy therapeutics for patients. It is an honor to have enrolled the first patient in the Microburst VNS Therapy Feasibility Study, and we look forward to the resulting impact it will have on this patient population,” Dr. O’Dwyer said in a press release.
The trial will consist of a cohort of 20 patients with primary generalized tonic-clonic seizures and a 20-patient cohort of patients with partial onset seizures, including complex partial seizures with or without secondary generalization.
Patients in the trial will be monitored for 15 months with a primary endpoint measuring the percent change in seizure frequency and stimulation-related adverse events as compared to a baseline. Brain activation in response to stimulation will be assessed using functional magnetic resonance imaging.
Secondary endpoints in the trial include changes from the baseline in seizure severity, quality of life, anti-epileptic drug use, suicidality and adverse events.
“LivaNova is launching this study to enrich our understanding of epilepsy patient populations and the significant role VNS Therapy can play in the overall management of this disease. Through the Microburst feasibility study, we have the opportunity to evaluate a prospective new feature for VNS Therapy where stimulation is delivered in higher frequency bursts rather than gradual intervals,” LivaNova neuromod GM Edward Andrle said in a prepared statement.
Earlier this month, LivaNova said it launched a new trial of its Perceval sutureless aortic valve implant in China as it pursues Chinese Registration of the device.