St. Jude Expects Epic HF CRT Approval By May 2004 NASPE/HRS Meeting
This article was originally published in The Gray Sheet
Executive Summary
St. Jude Medical is lowering average selling prices for its U.S. ICDs and pacemakers by roughly 5% to counter Guidant and Medtronic's strategy of "bundling" cardiac resynchronization therapy defibrillators (CRT-D) with traditional ICDs and pacemakers
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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...