In Brief: Angeion
This article was originally published in The Gray Sheet
Executive Summary
Angeion: Company resumes U.S. clinical implants of its Sentinel series of implantable cardioverter defibrillators immediately following FDA sign-off on Jan. 26, the firm states. The company had temporarily suspended implants of the Sentinel series, including 2000, 2010, 2011 and 2012 models, in November 1997 following five incidents in which battery voltage depleted prematurely due to a defective capacitor ("The Gray Sheet" Nov. 17, I&W-3). To correct the problem, Angeion changed its manufacturing process to incorporate a new capacitor component, and the firm has modified the monitoring schedule for patients implanted with the ICDs. Angeion filed a premarket approval application for the devices in June 1997 that is currently under review ("The Gray Sheet" June 23, In Brief)...