LivaNova PLC (LIVN) announced today that its latest VNS Therapy systems received FDA approval for expanded MRI labeling.
This affirmed that LivaNova VNS Therapy as the only epilepsy device approved by the FDA for MRI scans.
This FDA approval ensures LivaNova VNS Therapy patients with the latest technology may visit any MRI center in the U.S. There they will have access to more than 90 percent of scans routinely performed on patients with epilepsy.
VNS Therapy is a minimally invasive treatment designed to prevent seizures before they start and stop them if they do. To date it has been used by more than 100,000 patients worldwide. More than one in three people with epilepsy has drug-resistant seizures. By this is meant seizures that persist in spite of treatment with antiepileptic medications. It is estimated that approximately one million people suffer from drug-resistant epilepsy in the U.S. alone.
The #LivaNova 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 who have partial onset seizures that are refractory to antiepileptic medications. Individual results may vary.