LivaNova has enrolled the first patient in a clinical study to examine the use of its new Microburst Vagus Nerve Stimulation Therapy (VNS Therapy) system.
This feasibility study will determine the initial safety and effectiveness of delivering VNS Therapy using high frequency bursts of stimulation (“Microburst”) in patients who have drug-resistant epilepsy (“DRE”).
LivaNova neuromodulation business franchise general manager Edward Andrle said: “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.”
The Microburst feasibility study’s first patient was enrolled by Dr. Rebecca O’Dwyer, Assistant Professor of Neurology, at the Rush University Medical Center in Chicago, Illinois. The pre-market study consists of two cohorts, enrolling up to 40 patients in total at approximately 15 sites in the United States. Cohort 1 will include 20 patients with primary generalized tonic-clonic seizures.
Cohort 2 will consist of 20 patients with partial onset seizures, including complex partial seizures with or without secondary generalization. Each patient will participate in the study for a minimum of 15 months. Primary endpoints will measure the percent change in seizure frequency and occurrence of stimulation-related adverse events in comparison to a patient’s baseline.
Activation of various areas of the brain in response to stimulation will be assessed using functional magnetic resonance imaging or fMRI. Secondary endpoints will be evaluated to assess changes from baseline in seizure severity, quality of life, antiepileptic drug use, suicidality and adverse events.
Source: Company Press Release