Datascope VasoSeal data comparison to Prostar study invalid, Perclose maintains.
This article was originally published in The Gray Sheet
Executive Summary
PERCLOSE PROSTAR DATA COMPARISON TO DATASCOPE VASOSEAL STUDY INVALID, Perclose maintains in a Sept. 24 response to Datascope's petition for review of FDA's approval of Prostar's premarket approval application. Prostar study time-to-ambulation results for patients in the control group were prolonged by factors not shown to be present in the VasoSeal study, Perclose says in defending FDA approval of its vascular hemostasis device. "These differences -- and other unknowns -- underscore the fundamental invalidity of trying to compare the results across these studies," the company states.
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