Boston Scientific has received CE Mark approval for its Vercise deep brain stimulation system in patients with dystonia, just 14 months after being CE-marked for patients with Parkinson’s disease.
The devicemaker plans to make the system available to European dystonia patients immediately.
Vercise uses implanted leads to deliver electrical signals to the brain and has been shown to be effective dealing with the challenges of secondary dystonia and its side effects. “It is the only system that uses multiple independent current control, allowing physicians to adjust the current flow in fine increments based on patient needs,” said company spokeswoman Denise Kaigler.
The brain stimulation system was approved in Australia for Parkinson’s disease in 2012 and has been approved in Israel and Colombia for the same indication. Vercise is still in investigational development in the U.S. — Lena Freund
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