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New FDA-Approved Device For Treatment Of Drug-Resistant Epilepsy Now Offering Hope To Patients In U.S.

New FDA-Approved Device For Treatment Of Drug-Resistant Epilepsy Now Offering Hope To Patients In U.S.

242545In just one month following FDA approval of the AspireSR® generator for the VNS Therapy® System, leading hospitals across approximately 40 states have begun providing this new treatment option for patients with drug-resistant epilepsy. As many as one third of people with epilepsy experience seizures that persist in spite of treatment with antiepileptic medications1. The VNS Therapy System is a minimally invasive option in which a medical device is inserted under the skin of the chest through an outpatient procedure. The device sends electrical signals through the vagus nerve to areas of the brain known to be associated with seizures. The new AspireSR generator detects relative heart-rate increases that are often associated with seizures in people with epilepsy and provides responsive stimulation2. This automatic stimulation feature is one reason AspireSR has spurred so much interest in the medical community. 

Experience the interactive Multimedia News Release here:http://www.multivu.com/players/English/7558151-cyberonics-aspiresr-treatment/

“AspireSR represents the first treatment option for drug-resistant epilepsy that embodies our patented DNA™ Technology (Detect, Notify, Act) – allowing for detection of changes in the body in order to provide immediate response and treatment when it is needed the most,” said Dan Moore, President and CEO of Cyberonics. “We believe this is where the market is headed and are pleased with AspireSR clinical trial results, showing that AspireSR may provide multiple benefits to patients, including reduced seizure duration, severity and frequency, and improved quality of life.2

More than 75 hospitals in the U.S. are already taking advantage of the new AspireSR technology, with the first procedures being completed by Children’s Hospital of Los Angeles; Children’s Hospital of New Orleans; Dayton Children’s Hospital in Ohio; Keck School of Medicine of USC; Mayo Clinic Hospital in Jacksonville, Fla.; Redmond Regional in Rome, Ga.; Stanford University Medical Center; Texas Children’s Hospital; and Valley Children’s Healthcare in Madera, Calif.

The first hospital to offer AspireSR on the West Coast was Children’s Hospital Los Angeles.

“We’re excited to provide AspireSR as a new treatment option for our patients suffering from drug-resistant epilepsy,” said Deborah Holder, M.D., neurologist and Director of the Epilepsy Center at Children’s Hospital Los Angeles.

“At Children’s Hospital Los Angeles, it’s a priority to look into options that will help our patients suffering from epilepsy. We know that many of our patients are concerned about ways to ensure their seizures are being treated – especially in situations when they aren’t able to intervene, like while they are sleeping at night,” said Dr. Holder.

Dayton Children’s Hospital in Ohio performed its first AspireSR procedure on June 30. The patient, 12-year-old Brooklyn Cassiano, had been experiencing seizures as often as one every three seconds – and grand mal seizures during the night every couple of months.

Brooklyn has been having uncontrollable seizures since she was 18-months-old, which has been extremely difficult for both her and her family,” said Stacey Bennett, Brooklyn’smother. “When we were informed about the new AspireSR device, we were beyond excited to give Brooklyn the opportunity to be one of the first patients in the country to try it. We are hopeful that this will give her more opportunities in the future to live her life to the fullest.”

Brooklyn’s procedure was performed by Kambiz Kamian, M.D., a neurosurgeon at Dayton Children’s Hospital.

“Like Brooklyn, many of our patients with drug-resistant epilepsy experience multiple seizures a day, so an intervention that is more automated in the way it detects changes in the body and delivers immediate treatment was something that was important to explore for our patients,” said Dr. Kamian. “We were thrilled to be able to offer the AspireSR generator as a new option to help our patients hopefully experience reduced seizures and improved overall quality of life.”

To learn more about the AspireSR generator for the VNS Therapy System, visit AspireSR.com and VNSTherapy.com.

INDICATION
The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures that are refractory to antiepileptic medications. Talk to your doctor to find out if VNS Therapy might be right for you.

SAFETY AND TOLERABILITY
AspireSR has demonstrated safety and tolerability comparable to currently available VNS Therapy. The AutoStim Mode is not recommended for patients being treated for cardiac arrhythmia or with a history of bradycardia. Important Safety Information: Incidence of adverse events following stimulation (>5%) were dysphonia, convulsion, headache, oropharyngeal pain, depression, dysphagia, dyspnea, dyspnea exertional, stress, and vomiting.

Visit cyberonics.com/isi to view a Brief Summary of full prescribing information.

  1. Kwan P., Brodie M.J. New England Journal of Medicine. 2000;342:314-19.
  2. Data on file, Cyberonics Inc. Houston TX.

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