A Medical Device Daily Staff Report
St. Jude Medical (St. Paul, Minnesota) said it has temporarily pulled its Brio deep brain stimulation device off the European market on the "fixable" issue of bodily fluids seeping into the device, according to an article on the Mass Device website.
St. Jude Medical pulled the Brio 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 (San Francisco) analyst Rick Wise.
The Brio system won CE mark approval in the European Union in September 2009 (Medical Device Daily, Sept. 10, 2009) and Australian approval in March 2010 (MDD, March 24, 2010). It is not yet approved for the U.S. market.
St. Jude 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.
The company expects the device to be off the market for 60-90 days, Wise wrote.
In the mean time, he wrote, St. Jude is recommending that European customers opt for the Libra DBS system, which has proven to be effective against both Parkinson's and severe depression in separate studies.