Abbott announces FDA review date for Xience V

Abbott Pharmaceuticals has announced that the US Food and Drug Administration (FDA) will review the company’s Pre-market Approval (PMA) submission for its XIENCE V Everolimus Eluting Coronary Stent System on November 29th.

The Circulatory Systems Devices Advisory Panel of the FDA received Abbott’s PMA in June this year and will decide whether to either approve or reject the application at the end of this month.

Abbott has stated that it expects to launch the Xience V in the US at the start of 2008 if it receives a positive result from the FDA.

The PMA for Xience V is the first to include data demonstrating the superiority of one drug eluting stent over another market leading product.

In addition, Xience V has been shown to have clinical superiority in the safety and efficacy endpoint of major adverse cardiac events.

Abbott’s PMA comprises of a subset of its two-year data from the Spirit II and Spirit III clinical trials which saw over 500 patients enrol.

The pharmaceutical company has stated that the data is consistent with the safety results from the Spirit III one-year data presented at last month’s Transcatheter Cardiovascular Therapeutics 2007 conference.

Earlier this month, Abbott announced the results of two carotid stenting trials which demonstrated results comparable to guidelines for patients treated with surgery.