St. Jude Epic HF
This article was originally published in The Gray Sheet
Executive Summary
Cardiac resynchronization therapy defibrillator (CRT-D) likely will not require FDA advisory panel review, the firm says. St. Jude expects a planned PMA submission this month to lead to approval in time for the NASPE/Heart Rhythm Society meeting in San Francisco May 19-22. Data from the pivotal RHYTHM trial will be presented at the American College of Cardiology meeting March 7-10 in New Orleans (1"The Gray Sheet" Dec. 1, 2003, In Brief)...
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Heart failure ICD resynchronization treatment data filing is slated for the week of Dec. 15. St. Jude expects the modular PMA submission, including the Epic HF and Atlas+ HF ICDs, Aescula 1055K and Quicksite 1056K left heart leads, will lead to approval by May 2004 (1"The Gray Sheet" Oct. 20, 2003, p. 22). Minimum enrollments for the Quicksite phase of the RHYTHM study were completed in Q3, but follow-up will wrap up the week of Dec. 1...