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St. Jude CRT misses launch target

This article was originally published in The Gray Sheet

Executive Summary

St. Jude Medical now expects to launch the Epic HF and Atlas+ HF resynchronization ICDs in July, following meetings with FDA reviewers, the company announces May 14. The firm previously had predicted FDA would approve both heart failure devices in time for a formal launch at the 2004 NASPE/Heart Rhythm Society Annual Scientific Sessions in San Francisco May 19-22. "FDA has not advised St. Jude of any substantive concerns with the PMA application or identified any open issues requiring the company's response," St. Jude explains in a release. The PMAs for both the Epic HF and Atlas+ HF are based on results from the RHYTHM ICD trial, which the company released at the American College of Cardiology conference in March...
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