St. Jude’s RHYTHM
This article was originally published in The Gray Sheet
Executive Summary
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...
You may also be interested in...
St. Jude Epic HF
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)...
St. Jude Expects Epic HF CRT Approval By May 2004 NASPE/HRS Meeting
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
California Court’s Inaction On TiO2 Prop 65 First Amendment Case Breeds New Lawsuits
The Personal Care Products Council seeks to stem the rising tide of titanium dioxide Proposition 65 lawsuits, requesting that a California court prohibit the state’s Attorney General and private enforcers from filing and/or prosecuting new suits against cosmetics companies failing to warn about potential TiO2 exposure.