Medical devices giant Medtronic Inc. (NYSE: MDT) will go before a Food & Drug Administration panel in early March to seek pre-market approval for its deep-brain stimulator for epilepsy.
The Center for Devices and Radiological Health set a March 12 date for its panel to discuss the company’s implantable device, which stimulates the left and right anterior nucleus of the thalamus to reduce seizures.
In December, Medtronic released the results of a pivotal study of 110 patients with an average age of 22 years old that showed a 41 percent reduction in seizures one year after implantation, a 56 percent reduction at two years and a 68 percent reduction at three years, in conjunction with anti-seizure medication.
The agency is seeking public comment on the issue until March 5.