Medtronic (NYSE:MDT) said today that it has secured a CE Mark for its Percept PC neurostimulator.
The medical device giant is touting Percept PC as the only deep brain stimulation (DBS) system launched in the EU with BrainSense technology — which senses and records brain signals while delivering DBS therapy to people with neurological disorders such as Parkinson’s disease.
BrainSense enables more personalized, data-driven neurostimulation treatment, according to Medtronic.
The EU approval of the Percept PC neurostimulator means that health providers can use it to treat symptoms associated with Parkinson’s disease (PD), essential tremor and primary dystonia — as well as epilepsy and obsessive-compulsive disorder. FDA in the U.S. is presently reviewing the device.
“DBS is proven to significantly improve motor function in people with Parkinson’s disease compared to standard medication alone — but with currently-available systems, physicians need to make therapeutic decisions mostly based on clinical assessments and patient-reported information,” said professor Andrea Kühn, head of movement disorders and neuromodulation at Charité University Hospital in Berlin.
“Percept PC with BrainSense technology is a game-changer. Patients and their care teams will have objective patient-specific brain signal data – including data recorded outside the clinic in patients’ everyday lives. With this technology, doctors could tailor therapy more precisely to the individual needs of each patient based on data from neuronal activity,” Kühn said in a news release.
The Percept PC neurostimulator is launching in Western Europe starting Jan. 15.
“Doctors can directly assess patients’ brain signals to inform and provide customized treatment for each patient,” said Mike Daly, VP and general manager of the Brain Modulation business, which is part of the Restorative Therapies Group at Medtronic. “Patients are empowered to take an active role in their therapy, and physicians can deliver data-driven, personalized therapy that fits the needs of today’s patients, now and in the future.”
