Product Licensing

FDA pre-market approval sought for optimization phase of heart synchronizer

Published in Medical Letter on the CDC and FDA, August 8th, 2004

St. Jude Medical Inc. (STJ) has submitted a pre-market approval supplement (PMAS) to the U.S. Food & Drug Administration (FDA) to add ventricle to ventricle timing to the biventricular pacing feature available in its cardiac resynchronization therapy device (CRT-D) product line.

Included in the line are the Epic HF CRT-D and Atlas+ HF CRT-D, which received FDA approval earlier. The results of the V-V timing optimization phase of the RHYTHM (resynchronization hemodynamic treatment for heart failure management) ICD clinical trial serve as the basis for the submission.

The V-V Optimization phase of the trial studied the effects of V-V timing, the delay...

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Source: Medical Letter on the CDC and FDA (2004-08-08)

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