The FDA just cleared Boston Scientific’s deep brain stimulation (DBS) system, Vercise, which treats Parkinson’s disease symptoms, such as involuntary movement, muscle rigidity and tremors. While the device has been marketed in Europe and other regions for several years, this is the company’s first cleared DBS device in the U.S.
Boston Scientific believes its system offers a technological leap by more precisely modulating the current to their DBS probes. The company noted that previous stimulation devices were based on pacemakers and provide uniform current. Vercise is built on cochlear implant technology, allowing it to modulate impulses between multiple contacts.
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Vercise device by Boston Scientific
“For you to have a sense of hearing, you really need high-precision stimulation to be able to stimulate auditory nerves to get that sense of clarity, so you’re not just listening to a single tone,” said Maulik Nanavaty, president and senior vice president, Neuromodulation, in a phone interview. “In this case, because you’re able to individually power each contact, you’re able to independently control the stimulation, which gives a high level of precision in creating the stimulation field for the patient.”
The device targets the brain’s subthalamic nucleus, which is about the size of a pea. Nanavaty noted the small target makes precision a necessity. “If you’re off by a couple of millimeters, you can create side effects worse than the benefits you’re targeting for,” he said.
Boston Scientific points to a couple of trials that validate its approach. The FDA clearance was based on the INTREPID study, which investigated the device’s safety and efficacy in 292 patients and met its primary endpoint. While complete INTREPID results will not be released publicly until next year, an earlier, smaller study, VANTAGE, showed significant benefits.
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“We were able to see 63 percent improvement in motor function 52 weeks from baseline,” said Nanavaty.
Many Parkinson’s disease patients initially manage their disease with medication, but continued degeneration can make these drugs less effective. Approved for Parkinson’s since 2002, DBS offers a potential alternative to improve quality of life. Still, there is some debate on whether this approach extends life. Nanavaty believes longer studies might show greater benefit.
“The studies are usually limited to three or four years,” he said. “I think that if you look at it longer term, you may be able to see the benefit.”
Boston Scientific joins a crowded field in the Parkinson’s DBS space, including Medtronic and St. Jude Medical, but hopes its new approach will help Vercise liftoff. The company is also exploring additional applications, such as stroke and Alzheimer’s disease, to help patients rewire their neural circuitry.
“There are a lot of redundancies in how the brain works, a lot of compensatory mechanisms,” said Nanavaty. “By creating this new stimulation pathway, you’re probably allowing the brain to bring some of the functionality back.”
Photo: John Lund, Getty Images