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Abbott completes Xience PMA filing

This article was originally published in The Gray Sheet

Executive Summary

Modular PMA filing for Abbott's Xience V everolimus-eluting coronary stent is complete with submission of final clinical data package, the firm says June 1. The submission also seeks approval for the device under the Promus label, to be marketed by Boston Scientific. Abbott, which predicts FDA approval and U.S. market launch in the first half of 2008, submitted the first module of the PMA last July. The submission is supported by data from Abbott's Spirit First, Spirit II and Spirit III trials; the most recent results were presented in May at the EuroPCR meeting in Barcelona (1"The Gray Sheet" May 28, 2007, p. 3)...
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