FDA Expands Age Range for VNS Device in Drug-Resistant Epilepsy
LivaNova announced that the Food and Drug Administration (FDA) has approved the VNS Therapy system for use in patients as young as 4 years old with drug-resistant epilepsy. Prior to the expanded indication, VNS Therapy was approved for use in patients aged ≥12 years.
Specifically, VNS Therapy is used as adjunct therapy to reduce the frequency of seizures in patients aged ≥4 years with partial onset seizures that are refractory to antiepileptic medications. The minimally invasive device is implanted during a short outpatient procedure. It works by sending mild pulses to the vagus nerve regularly throughout the day to prevent onset of seizures. An extra dose of therapy—given automatically or manually—may stop or shorten the seizure, lessen its intensity, and reduce recovery time.
Across various clinical studies, 80% of patients saw an improvement in overall quality of life. Study patients reported a 50% reduction in seizure severity as well as an improvement in mood among 49% of patients. Improvements in memory and achievement were seen in 38% and 39% of patient, respectively. Moreover, patients reported a 64% reduction in seizure worry.
VNS Therapy can be used along with other medicine and treatments; no drug interactions have been reported. VNS Therapy is contraindicated in patients after a bilateral or left cervical vagotomy. The most frequent adverse events from stimulation include horaseness, paresthesia, dyspnea, sore throat, and coughing.
For more information call (888) 867-7846 or visit VNSTherapy.com.