Business Wire05.02.18
LivaNova PLC has launched and 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 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,” said Edward Andrle, LivaNova’s general manager of its Neuromodulation business franchise. “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, Ill. 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.
“At the Rush Epilepsy Center, we are very dedicated to research and advancing the field of epilepsy therapeutics for patients,” said O’Dwyer. “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.”
VNS Therapy received CE Mark in 1994 and U.S. Food and Drug Administration approval in 1997 as an adjunctive treatment for drug-resistant epilepsy. The system consists of two implantable components: a programmable electronic pulse generator that is connected to a bipolar electrical lead, which sends mild pulses to stimulate the vagus nerve at regular intervals throughout the day.
LivaNova PLC is a global medical technology company built on nearly five decades of experience and a relentless commitment to improve the lives of patients around the world. LivaNova’s technologies and breakthrough treatments provide meaningful solutions for the benefit of patients, healthcare professionals and healthcare systems. Headquartered in London, United Kingdom, LivaNova has a presence in more than 100 countries worldwide. The company currently employs more than 4,500 employees, inclusive of approximately 900 employed by its CRM business franchise. LivaNova operates as three business franchises: Cardiac Surgery, Neuromodulation, and Cardiac Rhythm Management, with operating headquarters in Mirandola, Italy; Houston, Texas; and Clamart, France; respectively.
“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,” said Edward Andrle, LivaNova’s general manager of its Neuromodulation business franchise. “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, Ill. 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.
“At the Rush Epilepsy Center, we are very dedicated to research and advancing the field of epilepsy therapeutics for patients,” said O’Dwyer. “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.”
VNS Therapy received CE Mark in 1994 and U.S. Food and Drug Administration approval in 1997 as an adjunctive treatment for drug-resistant epilepsy. The system consists of two implantable components: a programmable electronic pulse generator that is connected to a bipolar electrical lead, which sends mild pulses to stimulate the vagus nerve at regular intervals throughout the day.
LivaNova PLC is a global medical technology company built on nearly five decades of experience and a relentless commitment to improve the lives of patients around the world. LivaNova’s technologies and breakthrough treatments provide meaningful solutions for the benefit of patients, healthcare professionals and healthcare systems. Headquartered in London, United Kingdom, LivaNova has a presence in more than 100 countries worldwide. The company currently employs more than 4,500 employees, inclusive of approximately 900 employed by its CRM business franchise. LivaNova operates as three business franchises: Cardiac Surgery, Neuromodulation, and Cardiac Rhythm Management, with operating headquarters in Mirandola, Italy; Houston, Texas; and Clamart, France; respectively.
