Medtronic scores European approval for rechargeable deep-brain stimulation implant
06 Dec 2023
Drug Approval
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Source: FierceBiotech
Medtronic previously secured U.S. and European approvals for its non-rechargeable Percept PC implant. The rechargeable Percept RC is currently under review by the FDA.
Medtronic has secured a European approval for a rechargeable version of its deep-brain stimulation implant, allowing for a smaller and thinner neuromodulation device.
The CE mark covers the company’s Percept RC neurostimulator and its BrainSense technology, which records the user’s brain signals so clinicians can chart a course for the therapy among patient-recorded events such as disease symptoms or medication side effects.
“We are excited about the potential of Percept RC to provide a comfortable, personalized DBS therapy to those living with Parkinson’s disease, essential tremor and primary dystonia. Percept RC is also the only rechargeable neurostimulator approved to serve patients with epilepsy,” Amaza Reitmeier, general manager for brain modulation at Medtronic, said in a statement.
The company said the neurostimulator will begin rolling out to Western Europe before adding additional regions; it is also available in Japan and is currently under review by the FDA.
Medtronic previously secured U.S. and European approvals for its non-rechargeable Percept PC implant. Both the RC and PC devices function similarly to a pacemaker, with an implanted power generator being placed in the chest and connected to the brain through electrical leads.
The Percept RC needs to be charged on a weekly basis and can go from 10% to 90% full in less than an hour. Medtronic said that its battery is designed to maintain more than 99% of its total capacity after 15 years.
In addition, with a comparatively lower profile, the RC can be placed deeper under the skin for less implant visibility, the company said. The device also carries MR-conditional labeling, allowing it to continue delivering therapy during full-body MRI scans.
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