Boston Scientific (NYSE:BSX) said it won CE Mark approval in the European Union for its Vercise deep-brain stimulation device for treating the movement disorder called dystonia.
The Vercise device is already approved in the EU for treating Parkinson’s disease. The new approval clears Natick, Mass.-based Boston Scientific’ Vercise for the treatment of intractable primary and secondary dystonia, according to a press release.
"The Vercise DBS System’s advanced technology has already demonstrated significant improvements in motor scores for patients with Parkinson’s disease as evidenced by the interim results from our Vantage multicenter clinical trial," Maulik Nanavaty, president of Boston Scientific’s neuromodulation division, said in prepared remarks. "With this approval we look forward to extending the use of this technology to improve the quality of life of patients with dystonia."
In June, Boston Scientific launched a clinical trial in the U.S. to examine the Vercise device in treating Parkinson’s. That indication won CE Mark approval and a nod Down Under back in 2012, meaning Vercise is on the market for treating Parkinson’s in in Europe, Israel, Australia and Colombia, according to a press release. The company touts the device as "the first system designed to selectively stimulate targeted areas of the brain in order to customize therapy and manage symptoms of Parkinson’s disease," according to the release.
The 1st Vercise dystonia implantation was done at the Charité Campus Virchow-Klinikum, led by Drs. Andrea Kühn and Dr. Gerd-Helge Schneider, Boston Scientific said.
"Historically, treatment of secondary dystonia has been challenging and efficacy was typically incomplete and partially limited by side effects. The Vercise DBS system represents an advancement in dystonia care by providing more flexible and unique programming options for targeted deep brain stimulation tailored to each individual," Kühn said in a statement.
"The device itself is designed to offer additional patient benefits including the longest battery life available for DBS and the smallest implanted stimulator footprint, especially important for our young patients," Schneider added.