Percept™ PC Neurostimulator with BrainSense™ Technology Receives FDA Approval

Friday, July 10, 2020

Medtronic has announced it received 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 personalized, data-driven neurostimulation treatment.

Mayo Clinic in Rochester, Minn., will be the first in the United States 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, M.D., 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 individualized 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’re 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 personalized 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 – to prepare for what’s next in DBS

“There is nothing that can replace clinical judgement in treating patients. For the first time, this technology gives clinicians feedback directly from the DBS patient’s brain,” said Mike Daly, vice president and general manager of the Brain Modulation business, which is part of the Restorative Therapies Group at Medtronic. “With such data-driven, patient-specific insights, we believe it can change the standard of care.”

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