Ireland-based medical technology company Medtronic has received the US Food and Drug Administration (FDA) approval for its Percept PC Deep Brain Stimulation (DBS) system.
The neurostimulation system uses BrainSense technology to chronically capture and record brain signals while delivering therapy to patients with neurologic disorders related to Parkinson’s disease, essential tremor, dystonia, epilepsy or obsessive-compulsive disorder (OCD).
It enables physicians to track patient brain signals and correlate them with patient-recorded actions or experiences, including symptoms, side effects, or medication intake, offering a personalised, data-driven neurostimulation treatment.
DBS is an individualised therapy delivered from a small pacemaker-like device, which can be placed under the skin of the chest or abdomen. It is designed to send electrical signals through very thin wires to a targeted area in the brain related to the symptoms of a neurological disorder.
In addition to BrainSense technology, the Percept PC DBS system uses several other features, including 3T and 1.5T full-body magnetic resonance imaging (MRI) scans, Enhanced Patient Programmer, and low-pulse width, which enables expanded stimulation options.
It also said to have improved battery longevity and contains a smart battery for personalised prediction of remaining battery life.
Medtronic Restorative Therapies Group Brain Modulation business vice-president and general manager Mike Daly said: “There is nothing that can replace clinical judgement in treating patients. For the first time, this technology gives clinicians feedback directly from the DBS patient’s brain.
“With such data-driven, patient-specific insights, we believe it can change the standard of care.”
Medtronic noted that the Mayo Clinic in Rochester will be the first in the US to implant the newly approved device.
Meanwhile, the company received secured CE mark approval for its TAVI system this week.
Earlier this month, Medtronic received an investment of $337m from Blackstone Life Sciences to scale up the development of its upcoming diabetes technologies.