|Medtronic notched the first implant of the Activa PC+S, a first-of-its-kind brain stimulator.--Courtesy of Medtronic|
Medtronic ($MDT) has developed a first-of-its-kind implant, pairing traditional deep-brain stimulation with sensing technology, and, after performing its first procedure, the company says the device has a chance to change the standard of care for neurological disorders.
A German Parkinson's patient was the first to be treated with Medtronic's Activa PC+S device, an implant that administers standard DBS therapy all while sensing and recording electrical activity in key areas of the brain, something impossible before now, the company said.
Researchers have long sought a closed-loop DBS device, one that could read brain signals and then administer stimulation to treat patient-specific needs. Activa PC+S is a milestone in the effort to create such a device, Medtronic said, giving investigators a first step toward a self-regulating brain stimulator.
Medtronic is making the CE marked device available to a select group of physicians around the world, and, with the data gathered from Activa's sensors, researchers can get new insights into how the brain responds to DBS.
For years, the method has been effective in treating Parkinson's, essential tremor, dystonia and other ailments, but the industry still has much to learn about how the conditions develop and progress, and the Activa PC+S will give researchers a never-before-seen look at how DBS affects brain function, Medtronic engineer Tim Denison said.
Any closed-loop system, whether a home thermostat or artificial pancreas, has three elements: a sensor to detect what's going on, an actuator to change it and an algorithm to unite the two, Denison said. With the latest Activa, Medtronic has bolted a sensor and algorithm system onto its proven DBS technology, part of an effort to "provide a mechanism for a disciplined development of a closed-loop system in the future," he said.
"The eventual goal of the PC+S is to define and clarify the biomarkers of neurological disorders," Denison said in an interview with FierceMedicalDevices. "The next step will be to use that information to define what the optimal policies are for closing the loop."
The FDA has cleared Activa PC+S only for investigational use, and the company expects to conduct its first U.S. implant in the coming months. The standard Activa PC is FDA-approved to treat Parkinson's disease, essential tremor and dystonia.
- read Medtronic's announcement