Xience and HeartMate II panel dates set
This article was originally published in The Gray Sheet
Executive Summary
FDA confirms that its Circulatory System Devices Advisory panel will review the PMA for Abbott's Xience V everolimus-eluting coronary stent on Nov. 29 and the PMA for Thoratec's HeartMate II left ventricular assist system as a bridge to transplant Nov. 30 in Gaithersburg, Md. Abbott will present two-year follow-up data from 500 patients in its SPIRIT II and SPIRIT III clinical trials (1"The Gray Sheet" Oct. 29, 2007, p. 6). Thoratec's application is based on data from a study of 279 patients