FDA grants breakthrough designation to brain stimulator for epilepsy

Medical device company Precisis GmbH announced its EASEE brain stimulator has received breakthrough device designation from the FDA, according to a press release.

The device is intended for patients with focal epilepsy and uses electrodes that are invisibly placed underneath the scalp to deliver a current to the affected brain region in a targeted and tailored manner. According to the release, multiple clinical studies have shown EASEE to have high efficacy for inhibiting epileptic seizures.

“We are very pleased with the success of the multicenter studies. One in three patients does not respond to the available drug therapy options,” Andreas Schulze-Bonhage, MD, PhD, who led the clinical studies, said in the release. “We are in need of new, innovative treatment options such as EASEE, which represent a real alternative for patients and only entail a low risk.”