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."
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.
"We checked in with STJ: the company expects the impact from this ‘recall’ to be immaterial to its 1Q12 and 2012 guidance," Wise wrote. "Brio’s uptake in Europe has been slow – with only 400 systems sold since the product gained CE Mark approval in September of 2009."
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.
