Cardiac Resynchronization

FDA approves high-voltage CRT-D device system

Published in Drug Week, July 30th, 2004

St. Jude Medical, Inc., (STJ) announced approval by the U.S. Food and Drug Administration (FDA) of its high-voltage cardiac resynchronization therapy (CRT-D) device system, including the Epic HF and Atlas+ HF ICDs (implantable cardioverter defibrillators) and the QuickSite left-heart pacing lead.

The approval was based on the results of the RHYTHM (Resynchronization HemodYnamic Treatment for Heart Failure Management) ICD study, which demonstrated a significant improvement in peak oxygen consumption, exercise duration, NYHA Class, and quality of life in patients treated with CRT.

Full U.S. market release of St. Jude Medical's high-voltage cardiac...

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Source: Drug Week (2004-07-30)

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