Medtronic has secured approval from the US Food and Drug Administration (FDA) for its Percept PC deep brain stimulation (DBS) system.
The Percept PC DBS neurostimulation system uses BrainSense technology to chronically capture and record brain signals, while offering therapy to patients with neurologic disorders associated with Parkinson’s disease, essential tremor, dystonia, epilepsy or obsessive-compulsive disorder (OCD).
Medtronic’s DBS neurostimulation system helps in providing more personalised, data-driven neurostimulation treatment, by enabling physicians to track patient brain signals and correlate these with patient-recorded actions or experiences such as symptoms, side-effects, or medication intake.
Mayo Clinic is the first US clinic to implant Percept DBS system from Medtronic
Mayo Clinic, located in Rochester of Minnesota, is the first US clinic to implant the new Percept PC DBS system.
Mayo Clinic neurologist Dr Bryan Klassen said: “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.”
The DBS is an individualised therapy delivered from a small pacemaker-like device, which is under the skin of the chest or abdomen, to pass electrical signals through very thin wires to a targeted area in the brain related to the symptoms of a neurological disorder, such as Parkinson’s disease.
Percept PC DBS system is claimed to be the only device eligible for 3T and 1.5T full-body MRI scans. It includes a smart battery that facilitates the personalised prediction of remaining battery life.
The low pulse width feature of the Percept PC DBS system helps to offer expanded stimulation options. In addition, the Percept PC system is designed to facilitate expanded capabilities in the future through software upgrades.
Medtronic restorative therapies group’s brain modulation business general manager and vice president 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.”
In January this year, Medtronic secured approval from the US FDA for an investigational device exemption (IDE) trial to assess the PulseSelect pulsed-field ablation (PFA) system.