St. Jude yanks Brio deep brain stimulator

March 29, 2012 by MassDevice staff

St. Jude Medical temporarily pulls its Brio deep brain stimulation device off the European market on the "fixable" issue of bodily fluids seeping into the device.

Brain vasculature

St. Jude Medical (NYSE:STJ) temporarily pulled its Brio deep brain stimulation Parkinson's disease treatment off the market over a "fixable" issue related to bodily fluids seeping into the implanted device and interrupting therapy.

The problem, which occurred in only 11 of the 400 Brio devices implanted so far, spurred a "Dear Doctor" letter, according to Leerink Swann analyst Rick Wise.

"There have not been any serious patient injuries reported," Wise wrote in a research note to investors today. "But about 8 patients have needed to have the device explanted and replaced due to inability to deliver the therapy."

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The Brio system won CE Mark approval in the European Union in September 2009 and Australian approval in March 2010. It is not yet approved for the U.S. market.

The St. Paul, Minn.-based device giant bills the device as "the world's smallest, longest-lasting rechargeable deep brain stimulation device for treating the symptoms of Parkinson's disease," physically about the size of a man's watch, according to a press release.