Reuters reports that The Wall Street Journal is challenging the validity of data that Boston Scientific has submitted to the FDA for approval of it Taxus Liberte coronary stent system. The study was completed in 2006.
The Wall Street Journal suggests that the analysis of the data is statistically flawed due to the use of an equation called the Wald interval. WSJ states that using various off the shelf statistical analysis software systems to process the data would yield unfavorable results. The equation, used by other companies in similar studies like Medtronic and Abbott Vascular, would not have resulted in negative outcomes for these respective companies.
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