St. Jude To Announce RHYTHM Data As ACC Crowd Buzzes About SCD-HeFT
This article was originally published in The Gray Sheet
Executive Summary
St. Jude Medical will present results from three pivotal cardiac rhythm management trials during the Annual Scientific Sessions of the American College of Cardiology in New Orleans, March 6-10
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American College Of Cardiology 2004 Scientific Sessions In Brief
Expanded Cypher use: Sirolimus-eluting stents are effective in treating lesions in relatively narrow vessels, according to eight-month data from the 257-patient SES-SMART trial comparing Johnson & Johnson/Cordis' Cypherwith the firm's bare-metal Bx Velocity. Binary restenosis was 9.8% and 53.1% for the Cypher and control groups, respectively; major cardiac event rates were 9.3% for Cypher and 31.3% for control. Mean vessel diameter was 2.2 mm; mean pre-procedure lumen diameter was 0.72 mm. Cypher currently is approved for vessels 2.5-3.5 mm in diameter...
American College Of Cardiology 2004 Scientific Sessions In Brief
Expanded Cypher use: Sirolimus-eluting stents are effective in treating lesions in relatively narrow vessels, according to eight-month data from the 257-patient SES-SMART trial comparing Johnson & Johnson/Cordis' Cypherwith the firm's bare-metal Bx Velocity. Binary restenosis was 9.8% and 53.1% for the Cypher and control groups, respectively; major cardiac event rates were 9.3% for Cypher and 31.3% for control. Mean vessel diameter was 2.2 mm; mean pre-procedure lumen diameter was 0.72 mm. Cypher currently is approved for vessels 2.5-3.5 mm in diameter...
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)...