First Implants of DBS System that Monitors Brain Activity During Therapy Delivery

Medtronic, Inc. has announced the first U.S. implants of a novel deep brain stimulation (DBS) system in research that may one day transform the treatment of devastating neurological and psychological disorders, such as Parkinson’s disease, essential tremor, dystonia, and treatment-resistant obsessive-compulsive disorder.

Background

We’ve been covering DBS therapy for a few years now, observing the progress of systems from Boston Scientific, St.Jude Medical and indeed Medtronic, all of which gives a clue to its potential. DBS therapy uses a surgically implanted medical device, similar to a pacemaker, to deliver mild electrical pulses to precisely targeted areas of the brain. The stimulation can be programmed and adjusted non-invasively by a trained clinician to maximize symptom control and minimize side effects.

More than 100,000 patients worldwide have received Medtronic DBS Therapy following its approval in many parts of the world, including Europe and the United States, for the treatment of the disabling symptoms of essential tremor, advanced Parkinson’s disease and chronic intractable primary dystonia, for which approval in the United States is under a Humanitarian Device Exemption (HDE). In Europe, Canada and Australia, DBS therapy is approved for the treatment of refractory epilepsy. DBS therapy is also approved for the treatment of severe, treatment-resistant obsessive-compulsive disorder in the European Union and Australia, and in the United States under an HDE.

Medtronic’s Activa® PC+S DBS system delivers DBS therapy while simultaneously sensing and recording electrical signals in key areas of the brain, using sensing technology and an adjustable stimulation algorithm. The system received CE Mark approval in January 2013 and is being made available in Europe for research use with select physicians. The first worldwide implant of the Activa PC+S system took place at Ludwig Maximilian University in Munich, Germany in August 2013, and the first implant in a patient with essential tremor in November 2013 at University Hospital of Würzburg in Germany.

While it is not approved by the FDA for commercial use in the United States, it is available to select physicians for investigational use only. As such it may offer researchers revolutionary insights into how neurological conditions develop and progress, as well as the brain’s specific responses to Medtronic DBS therapy. To this end the first two US implants have taken place at Stanford Hospital & Clinics and the UC San Francisco (UCSF) Medical Center in patients with advanced Parkinson’s disease.

Physician comments

“While DBS therapy is widely proven to treat symptoms of advanced Parkinson’s disease and other movement disorders, the ability to collect and analyze data demonstrating how the brain responds to this therapy was not possible until now,” said Dr. Philip Starr, M.D., Ph.D., professor of neurological surgery and surgical director of UCSF’s Bachmann-Strauss Dystonia and Parkinson Foundation Center of Excellence. “At UCSF we are leveraging the broad capabilities of this new device by implanting recording electrodes in the deep brain structures that have traditionally been targeted by DBS and also in crucial areas of the cerebral cortex. This may help give us a better understanding of how Parkinson’s disease and other devastating conditions progress in the brain.”

“Activa PC+S represents a significant advancement in research for DBS therapy, and we look forward to partnering with additional researchers worldwide in the interest of advancing the understanding of how brain disorders progress, and how the brain responds to stimulation,” said Lothar Krinke, Ph.D., vice president and general manager of the Deep Brain Stimulation business at Medtronic.

Company comments

“The ability to sense brain signals while delivering Medtronic DBS therapy brings us closer to the opportunity for a closed-loop DBS system, which has the potential to provide truly personalized therapy for patients,” said Tim Denison, Ph.D., engineering director at Medtronic, whose team’s work over the last decade helped lead to first human uses of the system.

Source: Medtronic, Inc.

 

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