St. Jude Medical's Genesis
This article was originally published in The Gray Sheet
Executive Summary
European launch of the ventricular resynchronization system for congestive heart failure and atrial fibrillation commences immediately following CE mark approval Jan. 25 for the Alliance catheter delivery system component. The Alliance, currently in U.S. clinical trials, is designed to facilitate the implanting of the Aescula left ventricular lead by allowing physicians to perform a venogram that provides radiographic assessment of patient anatomy, thereby reducing overall procedure times. The Genesis also incorporates the Frontier biventricular stimulation device. Separately, a U.K. Medical Devices Agency Implantable Pacemaker/ICD Technical Notes update cites a Dec. 18, 2000 letter warning that St. Jude pacer models 2033, 2037, 2049, and 608 potentially could be affected by sudden loss of output without observation of "end of life" or "recommended replacement time" indicators. While 41 pacemakers worldwide have shown a sudden loss of battery output, the firm estimates that 671 pacemakers distributed in the U.K. before July 1995 could be affected