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)...