LivaNova (NSDQ:LIVN) said today it won expanded CE Mark approval in the European Union for its Vagus Nerve Stimulation Therapy systems, now labeled as safe for 1.5T and 3T magnetic resonance imaging scans.
The labeling change for the London-based medical device maker includes its AspireHC and AspireSR devices, allowing patients with existing devices to safely have MRI scans without the need for special equipment.
“In addition to offering patients more seizure-free moments, we can now better support comprehensive epilepsy treatment throughout a patient’s lifetime,” neuromodulation biz GM Jason Richey said in a prepared statement.
LivaNova’s VNS Therapy systems are indicated for use as an adjunctive therapy to reduce frequency of seizures in patients with epileptic disorders dominated by partial seizures, or generalized seizures that are refractory to seizure medication.
“The CE Mark comes one month after we received U.S. FDA approval for similar expanded MRI labeling. Earning CE Mark and FDA approval to expand our MRI labeling removes a barrier to care for patients with drug-resistant epilepsy,” CEO Damien McDonald said in a press release.
In June, LivaNova said it won FDA approval of its VNS Therapy system for patients as young as 4 years of age with partial onset seizures that are refractory to antiepileptic medications.