The global market for deep-brain stimulation devices is about $600 million and is growing around 10 percent a year.
About 10,000 patients are treated with DBS per year, but they are a minority. Most of the more than 1 million Americans who are living with the disease today take drugs like dopamine-boosting levadopa medications, in addition to behavior changes like getting more rest and exercise. Typically a DBS device would be considered only after those therapies have waned in effectiveness.
While drug therapies often consist of chemicals intended to change dopamine levels, implantation of a deep-brain stimulator is intended to electrically stimulate parts of the brain like the subthalamic nucleus. Success with a DBS device can mean that patients can lower their levadopa doses while still getting relief from tremors, muscle rigidity, slow movements and other symptoms.
The Vercise, which has been approved in Europe for years, is designed to use independently powered electrodes to increase precision and avoid the negative side effects of DBS therapy that affects the brain beyond the intended target. The device has an implanted battery that can be recharged through the skin.
"In basic terms, it really provides a constant optimized therapy for the patient," said Maulik Nanavaty, senior vice president with Boston Scientific's neuromodulation division. "And it's rechargeable through the skin, so the patient has 15-plus years of rechargeable battery life."
The FDA approved the device for U.S. patients after seeing the safety and effectiveness results of a 40-person study in Europe called the Vantage trial, plus the early safety results of an ongoing clinical trial with 292 patients at 23 sites called the Intrepid study. Boston Scientific said Intrepid reached its primary endpoint of change in symptom control during waking hours, but the exact data will be published next year.
Dr. Jerrold Vitek, head of the neurology department at the University of Minnesota and coordinating principal investigator for the Intrepid study, said the rounded shape of the Vercise's power generator may reduce surgical infections while the rechargeable battery is supposed to cut down on the number of generator-replacement surgeries.
"Clearly, there is a benefit," Vitek said. "How much? That's what we're going to be looking at."
The device seems to have also stimulated the DBS market, he said, by introducing new features and generating market competition, which should be good for patients. "It is really nice to have more competition in the marketplace right now," Vitek said.

http://www.startribune.com/vercise-is-designed-to-more-precisely-target-deep-brain-stimulation/464457963/