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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 And...

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.

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.

FDA Approves VNS Therapy Treatment for Drug-Resistant Epilepsy in Children as Young as Four Years Old

It was announced today that the FDA approves VNS Therapy® system (“VNS Therapy”) in patients as young as four years of age with partial onset seizures that are refractory to antiepileptic medications. This groundbreaking achievement makes VNS Therapy the first and only device that is FDA approved for drug-resistant epilepsy in this pediatric population. Previously, VNS Therapy was FDA approved for patients ages 12 and older. With this new indication, many children living with devastating drug-resistant seizures will have the opportunity for treatment beyond medication.

VNS Therapy Receives FDA Approval for Expanded MRI Labeling

VNS Therapy Receives FDA Approval for Expanded MRI Labeling “LivaNova” announced today that its latest VNS Therapy® systems received FDA approval for expanded MRI labeling, affirming VNS Therapy as the only epilepsy device approved by the FDA for MRI scans. This FDA approval ensures VNS Therapy patients with the latest technology may visit any MRI center in the U.S. and have access to more than 90 percent of scans routinely performed on patients with epilepsy.

Study shows continuous electrical stimulation suppresses seizures in patients with epilepsy

When surgery and medication don’t help people with epilepsy, electrical stimulation of the brain has been a treatment of last resort. Unfortunately, typical approaches, such as vagal nerve stimulation or responsive nerve stimulation, rarely stop seizures altogether. But a new Mayo Clinic study in JAMA Neurology shows that seizures were suppressed in patients treated with continuous electrical stimulation. Epilepsy is a central nervous system disorder in which nerve cell activity in the brain becomes disrupted. In the study, 13 patients with drug-resistant epilepsy were deemed unsuitable for resective surgery, which removes a portion of the brain — usually about the size of a golf ball — that was causing seizures. When patients are evaluated for surgery, a grid of electrical contacts ...

VNS technology could help improve lives of people recovering from stroke

A new study involving UT Dallas researchers shows that vagus nerve stimulation (VNS) technology could help improve the lives of hundreds of thousands of people who suffer weakness and paralysis caused by strokes. The study, published in the journal Stroke, marks the first time that VNS has been tested in individuals recovering from stroke. VNS already has been approved by the U.S. Food and Drug Administration as a treatment for certain illnesses, such as depression and epilepsy. It involves sending a mild electric pulse through the vagus nerve, which is in the neck. Stimulating this nerve relays information about the state of the body to the brain and encourages it to reorganize in a process called neural plasticity.

In Epilepsy, Sleep Apnea Can Be at Play Even When You Least Expect It

Case shows importance of sleep apnea screening in all epileptic patients By Nancy Foldvary-Schaefer, DO, MS Presentation A 25-year-old man presented to Cleveland Clinic’s Epilepsy Center in 2002 with epileptic seizures occurring as frequently as once a day and convulsions occurring about once a week. Diagnosed with epilepsy at age 15, he had never been able to work outside the home or drive a car. The patient was evaluated at Cleveland Clinic for surgical therapy, as his seizures were not controlled by anti-epileptic medications (oxcarbazepine and levetiracetam, prescribed at another institution). Because we were unable to localize his seizures, he was not a candidate for resection. He did receive a vagus nerve stimulator (VNS), which also proved ineffective in controlling his seizures. Ev...

Cyberonics AspireSR Generator, VNS Upgrade, Improves Care, Reduces Seizures

Medical technology provider Cyberonics, Inc.’s (CYBX – Analyst Report) novel AspireSR generator, which supports the company’s pioneering Vagus Nerve Stimulation (VNS) Therapy system, recently received the FDA nod for its commercial launch in the U.S. market. Management will provide updates on the AspireSR generator’s commercialization in the U.S. market in its upcoming earnings report, slated to be released on June 4, 2015. Cyberonics’ VNS Therapy system is an FDA-approved medical device that offers unique cure for treating drug-resistant epilepsy and treatment-resistant depression (TRD). Statistically, epilepsy is the fourth most common neurological disorder and one in every 26 people has a chance of developing epilepsy at some point in their lifetime. This reflects the huge growth ...

Reducing epileptic seizures with deep brain stimulation

As her Emory doctors told Paula Moreland how they were proposing to treat her seizures, her eyes grew wide. Moreland’s mother, who was with her at the appointment, said, “Just listen to them, babe.” A surgeon would implant an electrical stimulation device deep within her brain. The device would deliver current to calm the storms of signals that would sometimes erupt and cause her to lose consciousness. Moreland had already seen several neurologists and tried a variety of anti-seizure drugs. At one point, she was taking seven different medications. “They didn’t seem to work, and they made me sick,” she says. “I went to talk with one doctor, and he threw up his hands. It was like he was saying, ‘I give up.’ ” Epilepsy seemed to have...

Direct brain responsive neurostimulator reduces seizures, improves quality of life

Piotr Olejniczak, MD, PhD, LSU Health New Orleans Professor of Neurology and Director of the Epilepsy Center, contributed to a study of the long-term effectiveness of the first direct brain responsive neurostimulator for partial onset, or focal, seizures that cannot be controlled with medication. The study found that responsive direct cortical stimulation reduces seizures and improves quality of life over an average of 5.4 years. The study is published in the February 24, 2015, issue of the journal, Neurology. The results are part of the Long-Term Treatment (LTT) Study, an ongoing seven-year multicenter prospective open-label study to evaluate the long-term efficacy and safety of the RNS® System. The technology, FDA-approved for adults with focal (in one part of the brain) seizures, contin...

Noninvasive VNS Device Proves Itself Safe and Effective

Non-invasive vagus nerve stimulation (nVNS) ‘improves the safety and tolerability of VNS making it more accessible and facilitating further investigations across a wide range of uses when compared with surgically implanted VNS’ according to a review in the European Journal of Neurology. The review then went on to look at the efficacy of both surgically implanted VNS and non-invasive VNS including electroCore’s gammaCore device.

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