FDA approves Percept PC neurostimulator with BrainSense technology

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Medtronic has announced it received US Food and Drug Administration (FDA) approval for the Percept PC deep brain stimulation (DBS) system. BrainSense technology makes Percept the first and only DBS neurostimulation system with the ability to chronically capture and record brain signals while delivering therapy to patients with neurologic disorders associated with Parkinson’s disease, essential tremor, dystonia, epilepsy or obsessive-compulsive disorder (OCD).

Physicians can now track patient brain signals and correlate these with patient-recorded actions or experiences, such as symptoms, side-effects, or medication intake. This enables more personalised, data-driven neurostimulation treatment.

Mayo Clinic in Rochester, USA, will be the first in the USA to implant the newly approved device. “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,” said Bryan Klassen, neurologist, Mayo Clinic. “We can now more precisely tailor therapy to the individual needs of each patient based on data from neuronal activity.”

DBS is an individualised therapy delivered from a small pacemaker-like device, placed under the skin of the chest or abdomen, to send electrical signals through very thin wires (leads) to a targeted area in the brain related to the symptoms of a neurological disorder, such as Parkinson’s disease.

“With movement disorders like Parkinson’s disease, even sharing a meal and holding utensils can be a challenge,” said John L Lehr, president and chief executive officer of the Parkinson’s Foundation. “We are excited by new treatments and clinical advancements that let people with Parkinson’s live fuller, more complete, lives.”

In addition to BrainSense technology, the Percept PC DBS system features several leading-edge innovations, including:

  • The only DBS system eligible for 3T and 1.5T full-body MRI scans, providing patients access to cutting-edge medical imaging
  • Smart battery for personalised prediction of remaining battery life providing elevated peace of mind while planning for device replacement
  • Improved battery longevity compared to Medtronic’s Activa PC neurostimulator (when using similar settings and functionality) in a smaller (reduced volume), ergonomic design for patient comfort
  • Low pulse width (duration of the pulse), providing expanded stimulation options
  • Enhanced patient programmer leveraging a user-friendly, custom-configured Samsung mobile device that allows patients to manage their therapy easily
  • Designed to facilitate expanded capabilities in the future via software upgrades

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