In Brief: Angeion
This article was originally published in The Gray Sheet
Executive Summary
Angeion: Receives FDA approval to expand U.S. clinical studies of its Sentinel 2000 and 2010 implantable cardioverter defibrillator systems and AngeFlex dual pass lead system to 35 centers -- adding 10 additional sites. The Minneapolis firm also has received approval to include the Sentinel 2011 and 2012 in its clinical studies. U.S. clinical testing of the Sentinel line began in March 1996 ("The Gray Sheet" Feb. 26, 1996, I&W-16). The company received CE Mark approval in 1996 for its 2000 and 2010 ICD systems and is seeking CE Mark for the 2011 and 2012...