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Medtronic receives European approval for Percept Deep Brain Stimulation device

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Medtech giant Medtronic has just received the European CE Mark for its deep brain stimulation device, Percept. Deep brain stimulation is a well-established technology that generates electrical signals that can control symptoms associated with Parkinson’s disease, epilepsy, OCD and other conditions. However, the Percept can also read brain signals, potentially giving brain specialists new capabilities to personalize treatment.

Medtronic’s Percept Deep Brain Stimulation System

Traditionally, physicians adjust DBS signals based on a patient’s diary entries, which can be imprecise. Medtronic believes that, by monitoring electrical signaling in the brain, Percept will provide doctors better information to make those adjustments.

“Now, they’ll be able to look at that data over the past three months and know when the stimulation is working well and when it’s not,” said Mike Daly, vice president and general manager of Medtronic’s Brain Modulation unit, in a phone interview. “They can then use those data to inform the program.”

Percept achieves this by monitoring local field potentials (LFPs), which are electrical signals generated around neurons. However, given the electricity generated by brain activity, they can be difficult to read.

“There’s a lot of different noise going on in the brain, and you have to take these local field potentials out of that noise, which is a really difficult scientific task to do,” said Daly. “It’s like standing next to a 757 airliner with the engines running and somebody is in the terminal whispering.”

Currently, Percept is being used in an open-loop configuration. The device records brain signals, which physicians review. With this data, they can adjust device settings to hopefully provide more therapeutic benefit.

However, Medtronic hopes to eventually transition to a closed-loop approach, in which the device can respond to LFPs in real time. The company is planning a clinical trial in May to test this adaptive sensing strategy, which Daly likens to a thermostat.

“If you have a fireplace, you turn the fire on and the room gets warmer, “he said. “If it gets too warm, you’ve got to put the fire out. But if you have a thermostat, you set it on 71 and when it gets to 68 or whatever, it’s supposed to go back up to 71. When it gets to 72, it goes back to 71.”

In addition to its sensing capabilities, the Percept is also compatible with both 1.5 and 3 Tesla MRIs. Medtronic has also given patients a more user-friendly device – a Samsung phone – to program their Percept within well-defined parameters. The next step for Medtronic is gaining FDA approval, which is in the works.

“We submitted (to the FDA) in October, and we expect probably mid-May from all indications,” said Daly. “We’ve been very open with them and have had a lot of pre-work with them about sensing.”

Photo: Thomas Pajot, Getty Images

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