
Medtronic has received the CE mark approval for BrainSense Adaptive deep brain stimulation (aDBS) and BrainSense Electrode Identifier (EI) in the EU and the UK.
The CE mark approval indicates that the BrainSense aDBS and EI solutions meet the standards required by the EU Medical Device Regulation (MDR).
In addition to the regulatory approval, the first patient programming was completed.
The programming was performed by Amsterdam University Medical Centre department of neurology neurologist and associate professor Martijn Beudel.
Medtronic neuromodulation business president Paolo Di Vincenzo said: “BrainSense technology is at the centre of personalising DBS therapy, and we are advancing this capability through innovation that builds on our sensing-enabled DBS platform.
“From improved precision for contact selection to automatically adjusting DBS therapy, these milestones mark significant advancements in our ability to customise care for people with Parkinson’s, and we’re just getting started.”
According to Medtronic, people with Parkinson’s disease (PD) have been benefitting from deep brain stimulation (DBS) technology, for three decades.
DBS technology involves the transmission of electric signals to the brain to disrupt certain unwanted movements.
Medtronic said that its BrainSense aDBS allows people with PD to benefit from real-time, adaptive therapy that adjusts stimulation based on a person’s unique brain activity.
Also, its BrainSense EI solution is designed to improve DBS programming by enabling optimal initial contact selection in less time.
Medtronic’s Percept DBS system, together with BrainSense will record and analyse brain signals, enabling therapies customised to each patient’s unique neurological patterns.
The medical technology company has pioneered incorporating brain-computer interface (BCI) technology into DBS therapy for patients with complex neurological conditions.
Medtronic neuromodulation marketing and strategy vice president and general manager Amaza Reitmeier said: “Medtronic remains the first and only company in the world to offer a complete sensing-enabled DBS system, and now we have enhanced this innovation to allow patients with Parkinson’s to spend less time thinking about their disease.
“Patients and clinicians have been eagerly awaiting these BrainSense technology enhancements, which represent another transformative step forward in our ability to personalise therapy for people living with Parkinson’s.”
BrainSense EI enhances precision by providing a detailed view of each patient’s unique brain signals and guiding clinicians to the exact location of the strongest signal.
It accurately identifies the optimal contact location using local field potentials (LFP) and alpha-beta activity to enable optimised and effective programming compared to the standard of care.
Medtronic neuromodulation international vice president Domenico De Paolis said: “BrainSense Electrode Identifier allows clinicians to now conduct accurate and precise initial programming, offering a level of personalisation unmatched in the field.
“Clinicians will appreciate less ambiguity and greater efficiency compared to the traditional method of electrode selection. CE Mark approval is just the first step in our effort to bring this new technology to customers around the world.”