LivaNova's latest VNS Therapy earns CE Mark for expanded MRI labeling
LivaNova PLC , a market-leading medical technology company, today announced its latest VNS Therapy Systems ("VNS Therapy") received CE Mark for expanded MRI labeling. VNS Therapy is now the only implantable device indicated for epilepsy therapy that allows patients to have high-quality 1.5T and 3T MRI scans without the need for special equipment.
"The CE Mark comes one month after we received U.S. FDA approval for similar expanded MRI labeling," said Damien McDonald, LivaNova's Chief Executive Officer. "Earning CE Mark and FDA approval to expand our MRI labeling removes a barrier to care for patients with drug-resistant epilepsy."
The labeling change applies to the latest VNS Therapy technology, which includes AspireHC®and AspireSR® devices. Now, patients who have or desire to have VNS Therapy can more easily receive routine MRI scans.
"In addition to offering patients more seizure-free moments, we can now better support comprehensive epilepsy treatment throughout a patient's lifetime," adds Jason Richey, LivaNova's President of North America & General Manager of the Neuromodulation franchise.
To date, more than 100,000 patients worldwide use VNS Therapy—a minimally invasive treatment designed to prevent seizures before they start and stop them if they do. More than one in three people with epilepsy has drug-resistant seizures, meaning seizures persist in spite of treatment with antiepileptic medications. To learn more, visit www.VNSTherapy.com or www.SeizureControl.com.
INTENDED USE/INDICATION - EPILEPSY - EU
The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in patients whose epileptic disorder is dominated by partial seizures (with or without secondary generalization) or generalized seizures that are refractory to seizure medications.
AspireSR™ (Seizure Response) features the Automatic Stimulation Mode which is intended for patients who experience cardiac rhythm increases that are associated with seizures.
Common side effects include hoarseness or changes in voice tone, prickling feeling in the skin, shortness of breath, sore throat and coughing. Visit www.VNSTherapy.com/important-safety-information to view safety and full prescribing information.
No hay comentarios:
Publicar un comentario