|Boston Scientific's Vercise deep brain stimulation system--Courtesy of Boston Scientific|
Boston Scientific's ($BSX) Vercise deep brain stimulation system isn't yet approved in the U.S., but it continues to rack up regulatory blessings overseas. In the latest advance, the product now has a CE mark to treat a neurological movement disorder known as dystonia.
Vercise DBS can now be used to treat intractable primary and secondary dystonia, which involves involuntary muscle contractions, and the patient base is not insignificant. The Massachusetts medical device giant said in its approval announcement that more than 500,000 people in Europe alone are faced with the condition. It's also the third most comment movement disorder after Parkinson's disease and essential tremor, Boston Scientific said.
So how is it different? The implant uses electrical signals targeted to specific areas of the brain. Also, it is used with 3-D imaging technology so physicians can zero in on those targeted areas and customize the treatment, an advance over existing standards of care and earlier competing products, the company noted.
Vercise DBS won a CE mark and Australian approval in 2012 to treat Parkinson's disease. Beyond Europe and Australia, it is also available for use in Israel and Columbia.
In the U.S., Boston Scientific launched a far-reaching trial of Vercise as a Parkinson's disease treatment. That effort will likely build on a previous trial that showed a 60% average improvement in motor function in 40 patients with the implant after 6 months, with 100% implant success.
Keeping the momentum going in other areas, Boston Scientific is preparing for a Dec. 11 hearing before the FDA's Circulatory System Device Panel to make its case for FDA approval of Watchman, a device designed to prevent strokes in patients with atrial fibrillation.
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