FDA Approves Medtronic’s Percept PC Deep Brain Stimulation System

The U.S. Food and Drug Administration (FDA) has approved the Percept PC Neurostimulator by Medtronic, designed to allow for a more individualized use of deep brain stimulation therapy in people with Parkinson’s disease and related disorders.

While this device is the fourth deep brain stimulation (DBS) system to be approved in the U.S., it is the first system able to sense and record brain signals while therapy is delivered. As such, it is expected to help doctors more precisely tailor treatment to a patient’s needs.

“Percept uses BrainSense technology, which captures brain signal data from implanted brain leads, combined with a patient diary system,” Joohi Jimenez-Shahed, MD, professor of neurology at Icahn School of Medicine at Mount Sinai, said in a news release by the Michael J. Fox Foundation.

“This device allows us to measure and record brain signals, which can be matched with a person’s symptoms as reported in the diary or what we see on exam. By looking at brain signals, we might be able to tell whether symptoms relate to medication wearing off or to dyskinesia, for example, and we can use this information to more precisely understand how a patient’s symptoms respond to DBS,” Jimenez-Shahed said.

“Eventually, we hope to be able to use this data to adjust DBS settings for more tailored and targeted treatment,” she added.

DBS is used to treat neurological disorders that include Parkinson’s, essential tremor, dystonia, epilepsy, and obsessive-compulsive disorder. Therapy is delivered via a small, implantable device that is somewhat similar to a pacemaker. Tiny wires inserted in the brain are used to send electrical signals from the device to specific brain regions, aiming to ease motor symptoms.

Percept is also the first approved DBS system that can be used in certain full-body MRI scans, allowing greater access to imaging for patients and clinicians, Medtronic reports in a press release.

The first U.S. center to implant the device will be the Mayo Clinic in Rochester, Minnesota, it added.

“Our goal is for patients to regain independence, and we know that DBS can significantly improve motor function in people with Parkinson’s disease compared to standard medication alone,” said Bryan Klassen, MD, a neurologist at the Mayo Clinic.

“As with any therapy, considering DBS and choosing between specific devices is about weighing pros and cons,” Jimenez-Shahed said. “Because Percept is a new approach, doctors and patients will learn together in the months ahead who are the best candidates for the new technology and the best ways to take advantage of what it has to offer.”