www.fdanews.com/articles/186440-livanova-receives-ce-mark-for-nerve-stimulation-device
LivaNova Receives CE Mark for Nerve Stimulation Device
April 17, 2018
LivaNova received a CE Mark for its Vagus Nerve Stimulation Therapy system SenTiva generator for treating drug-resistant epilepsy.
The implantable device can detect seizures and automatically deliver an extra dose of therapy. The generator is also designed to log events including a patient’s body position and heart rate fluctuations. The system includes a tablet and a wireless programming wand to deliver personalized treatment.
The product received FDA clearance in October 2017.