LivaNova Launches Study to Assess VNS Therapy in Drug-resistant Epilepsy Patients

LivaNova Launches Study to Assess VNS Therapy in Drug-resistant Epilepsy Patients

September 12, 2018:  LivaNova PLC announced the first implanted patient and official launch of a global registry to evaluate the use of LivaNova’s Vagus Nerve Stimulation Therapy® (VNS Therapy) System for patients with drug-resistant epilepsy (DRE), which affects nearly one in three people with epilepsy.1 The Comprehensive Outcomes Registry in Subjects with Epilepsy Treated with VNS Therapy (CORE-VNS) study will enroll up to 2,000 patients with five-year follow-up data, yielding one of the largest data sets in the world for DRE patients treated with various generations of VNS Therapy. Data from CORE-VNS will contribute to the body of research related to this disease state and advance the science behind VNS Therapy by evaluating the safety, effectiveness and clinical outcomes for patients.

“By following these patients for five years, we will gain a significant amount of high-quality, real-world clinical data on VNS Therapy as an adjunctive treatment for drug-resistant epilepsy”

The registry will include up to 80 sites globally, collecting outcomes in real-world settings by following participating patients for up to five years after treatment begins. Documented clinical outcomes will include seizure frequency, seizure severity, quality of life, quality of sleep, antiepileptic drug use, and seizure-related emergency visits and hospitalizations.

“Many patients with drug-resistant epilepsy have tried numerous treatment options with limited results. The CORE-VNS study will give us a greater understanding of the drug-resistant epilepsy patient population around the world and the role VNS Therapy can play in the overall management of this disease,” said Bryan Olin, LivaNova’s Senior Vice President of Clinical, Quality Assurance and Regulatory Affairs. “Additionally, this study will allow us to evaluate the latest advancements in VNS Therapy, including the capability to track and use real-time patient data to inform treatment.”

Dr. Kore Liow, FACP, FAAN, from the Comprehensive Epilepsy Center at Hawaii Pacific Neuroscience and Clinical Professor at the University of Hawaii John Burns School of Medicine, has enrolled the most patients to date in the CORE-VNS registry in preparation for VNS Therapy implants. “By following these patients for five years, we will gain a significant amount of high-quality, real-world clinical data on VNS Therapy as an adjunctive treatment for drug-resistant epilepsy,” said Liow.

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.

For more information on VNS Therapy, please visit www.VNSTherapy.com.

To learn more about the study and locations go HERE. 

 

About VNS Therapy for Epilepsy

VNS Therapy is clinically proven safe and effective for the treatment of drug-resistant epilepsy for adults and children. VNS Therapy is designed to prevent seizures before they occur and stop them if they do. It is a unique treatment approach developed for people with drug-resistant epilepsy—a condition that affects one in three people with epilepsy. For more information, visit www.VNSTherapy.com or www.VNSTherapy.co.uk.

 

Severe depression: Vagus nerve stimulator improves lives

Severe depression: Vagus nerve stimulator improves lives

For people with treatment-resistant depression, adding vagus nerve stimulation to medication can drastically improve their quality of life, concludes a new study.

People with severe depression may benefit from the neurostimulation technique ‘vagus nerve stimulation.’

The National Institute of Mental Health suggest that over 16 million people in the United States have had at least one episode of major depression in the past year.
Of these, more than 10 million adults report that the condition severely impaired their quality of life.

There are a variety of treatments available for depression, including therapy, medication, and making changes to one’s lifestyle. However, for some, these therapies are not enough to relieve the symptoms and improve quality of life.

Some with treatment-resistant depression turn to neurostimulation. One type of neurostimulation is vagus nerve stimulation (VNS).

In VNS, a device is fitted in the patient’s chest or neck, under the skin. These devices send pulses of electrical stimulation to the vagus nerve, which starts in the brain, goes through the neck, and ends in the chest and abdomen.

However, does VNS really improve the quality of life of those who opt for it? A new study, just published in The Journal of Clinical Psychiatry, aims to answer this question.

The researchers were led by Dr. Charles R. Conway, a professor of psychiatry at Washington University in St. Louis, MO.

Source: By A. Sandoiu/fact checked by J. Collier for MedicalNewsToday.com

LivaNova Commences Clinical Study to Evaluate Treatment Outcomes for Novel Microburst VNS Therapy System

LivaNova Commences Clinical Study to Evaluate Treatment Outcomes for Novel Microburst VNS Therapy System

LivaNova today announced the launch and enrollment of the first patient in a clinical study to examine the use of LivaNova’s 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”.

“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, 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.
“At the Rush Epilepsy Center, we are very dedicated to research and advancing the field of epilepsy therapeutics for patients,” said Dr. 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.
For more information on VNS Therapy, please visit www.VNSTherapy.com.

SenTiva Approved for Treatment of Epilepsy

SenTiva Approved for Treatment of Epilepsy

Device billed as smallest, lightest responsive therapy for drug-resistant epilepsy

 
The SenTiva implantable generator and Vagus Nerve Stimulation (VNS) Therapy Programming System (LivaNova USA) have received FDA approval for the treatment of patients with drug-resistant epilepsy.

 
SenTiva is the smallest and lightest responsive therapy for epilepsy, LivaNova says. The new VNS Therapy Programming System features a wireless wand and new user interface on a small tablet. Together, the components offer patients with drug-resistant epilepsy a physician-directed customizable therapy with smart technology and proven results to reduce the number of seizures, lessen the duration of seizures, and enable a faster recovery, LivaNova says. (more…)

What is the vagus nerve?

What is the vagus nerve?

The vagus nerve is the longest and most complex of the 12 pairs of cranial nerves that emanate from the brain. It transmits information to or from the surface of the brain to tissues and organs elsewhere in the body.

The name “vagus” comes from the Latin term for “wandering.” This is because the vagus nerve wanders from the brain into organs in the neck, chest, and abdomen. (more…)

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